BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE 3D PATCH MESH

    MDR report key: 3061847 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03981
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K010722
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - GASTROINTESTINAL REFLUX; CONSTIPATION. PAIN OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT A FAILED RNY REVISION PROCEDURE ALONG WITH A PARTIAL SMALL BOWEL RESECTION ON (B)(6) 2009 AND MESH WAS IMPLANTED TO KEEP THE POUCH FROM STRETCHING OUT AGAIN. THE PATIENT DEVELOPED MARGINAL ULCERS, GASTRIC ALSO DUODENAL AND THEIR WEIGHT NEVER STABILIZED. THE PATIENT ALSO EXPERIENCED SEVERE PAIN, ONGOING NAUSEA, RECURRENT VOMITING, EXTREME GASTROINTESTINAL REFLUX, EXTREME CONSTIPATION AND ASSOCIATED PAIN WITH BOWEL MOVEMENTS DECREASING TO ABOUT EVERY 10-14 DAYS, CHRONIC DEHYDRATION WITH ASSOCIATED ANEMIA, EXHAUSTION, AND DIFFICULTY WITH DAILY FUNCTIONING. EVENTUALLY THE PATIENT COULD ONLY CONSUME LIQUIDS, PROTEIN SHAKES AND CRACKERS. ALL SYMPTOMS INCREASED OVER TIME. THE PATIENT'S CALORIC INTAKE WAS OFTEN ONLY ABOUT 400-500 CAL/DAY. THE PATIENT REPORTED THAT IT WAS CLEAR THAT THE GASTRIC POUCH WAS NOT EMPTYING. AFTER NUMEROUS DIAGNOSTICS, THE PATIENT CONSENTED TO SURGERY AND THE MESH WAS REMOVED ON (B)(6) 2012. THE STOMA OPENING WAS VERY CONSTRICTED DUE TO EXCESSIVE SCARRING FROM THE MESH. THE SURGEON HAD TO REMOVE A SECTION OF THE POUCH IN ORDER TO TAKE OUT THE IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162745 PROLENE 3D PATCH MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention