Align Retropubic Urethral Support System

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DEVICE: Align® R Retropubic Urethral Support System ...

    https://accessgudid.nlm.nih.gov/devices/00801741016172
    A sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

DEVICE: Align® RS Retropubic/Suprapubic Urethral Support ...

    https://accessgudid.nlm.nih.gov/devices/00801741016196
    A sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

MAUDE Adverse Event Report: BARD BARD ALIGN R RETROPUBIC ...

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2558043
    I was implanted with a bard align r retropubic urethral support system on (b)(6) 2010. The reference # is (b)(4) with lot #huudo014, size was a few centimeters. The reason for the sling urethropexy being implanted was for urinary stress incontinence. In addition to that procedure, a hysterectomy, cystocele repair and cystoscopy was performed.

Bard Davol, BRD100R, Bard Align R Retropubic Urethral ...

    https://www.esutures.com/product/1-expired/26-bard-davol/595-pelvic-health/46227343-bard-align-r-retropubic-urethral-support-system-BRD100R/
    The ALIGN® Urethral Support System is a suburethral sling device intended for the treatment of female stress urinary incontinence.

Fatal Injury of the Small Intestine during Retropubic ...

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4628685/
    We describe a case of injury of the small intestine in a patient who underwent placement of Align R retropubic urethral support system (BARD). Absence of characteristic symptoms of the bowel injury and peritonitis led to a rapid development of sepsis, multiple organ failure, and death.Cited by: 3

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON ...

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3596042
    Qty 9- align r retropubic urethral support system. Qty 1- align rs retropubic/suprapubic urethral support system. Qty 6- align s suprapubic urethral support system. Qty 8- align to trans-obturator urethral support system - halo. Qty 5- align to trans-obturator urethral support system - hook.

DEVICE: Align® RS Retropubic/Suprapubic Urethral Support ...

    https://accessgudid.nlm.nih.gov/devices/00801741016202
    AccessGUDID - Align® RS Retropubic/Suprapubic Urethral Support System without Dilator (00801741016202)- ALIGN®Urethral Support System, Retropubic & Suprapubic w/o dilator Skip to Main Content U.S. National Library of Medicine NLM

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON ...

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2944027
    The instructions for use states in the adverse events: "complications associated with the proper implantation of the align to urethral support system may include, but are not limited to: postoperative hematoma, which may occur following the implant procedure.

MAUDE Adverse Event Report: BARD SHANNON LIMITED ALIGN R ...

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1549287
    Bard align r sling, retropubic urethral support system, ref brd100r, exp date 2011-08, was being implanted. As the trocars were being pulled out, the first side of the sling cracked, the sling was removed. No patient harm. Another product was used to complete the procedure without further incident.



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