BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3040265 · Received March 18, 2013

    Report

    Report Number
    9615742-2013-00196
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    December 18, 2006
    Report Date
    February 21, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(5). SUPPLEMENTAL MDR# 01 SENT TO FDA ON 01/19/2015.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. MULTIPLE PRODUCTS. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00898 AND 1018233-2013-00899.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED,COMPLAINS OF LEFT FLANK PAIN AND URINARY RETENTION. COMPLAINS OF RECURRENT PROLAPSE, INCREASE IN PELVIC PAIN AND PRESSURE WITH WALKING, SUPRAPUBIC PAIN, INCONTINENCE, DYSPAREUNIA AND LEAKAGE OF URINE - SCHEDULED FOR SURGERY. UNDERWENT TRACHELECTOMY, BILATERAL RETROPERITONEAL SACROSPINOUS LIGAMENT COLPOPEXY, VAGINAL PARAVAGINAL REPAIR AND ANTERIOR COLPORRHAPHY. URINARY URGENCY AND FREQUENCY, PAINFUL BOWEL MOVEMENT AND RECTAL PAIN. SHE HAD ONLY SMALL AMOUNT OF DISCHARGE WITH RESOLUTION OF HER PROLAPSE SYMPTOMS; HOWEVER SHE CONTINUED WITH PERSISTENT PAIN IN HER LEFT INFERIOR GLUTEAL DISTRIBUTION WHICH WAS DIAGNOSED AS PUDENDAL NEUROSTHENIA POSSIBLY RELATED TO SUTURING PLACEMENT. ON EXAMINATION, A TAUT (MUST BE TAUT) AREA THAT IS EXQUISITELY TENDER IN THE LEFT APEX, CONSISTENT WITH A SUTURE SEEN. DUE TO COMPLICATIONS DUE TO GENITOURINARY DEVICE, IMPLANT AND GRAFT, LEFT BUTTOCK PAIN AND PELVIC PAIN SHE WAS SCHEDULED FOR REVISION SURGERY. UNDERWENT REVISION OF PROSTHETIC VAGINAL GRAFT AND PERMANENT SUTURE, VAGINAL APPROACH AND CYSTOURETHROSCOPY. NO. AS PER THE AVAILABLE MEDICAL RECORDS, THE PATIENT DID NOT PRESENT WITH ANY SERIOUS COMPLICATIONS AND DID NOT UNDERGO ANY ADDITIONAL SURGERIES. PER THE LAST AVAILABLE MEDICAL RECORD ON (B)(6) 2013, SHE REPORTED NO PAIN BUT HER OPERATIVE SITE EXAMINATION REVEALED SOME RESIDUAL SUTURE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112245 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA ZGB00317

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| URETEX TO2 URETHRAL SUPPORT SYSTEM