BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1972880 · Received January 28, 2011

    Report

    Report Number
    3005099803-2011-00242
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: ALTHOUGH THE EXACT PATIENT AGE IS UNAVAILABLE, IT IS REPORTED THAT THE PATIENT IS (B)(6). THE DEVICE HAS NOT BEEN RECEIVED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. THE REPORTED LOT NUMBER, 1ML0060902, COULD NOT BE VERIFIED. CONSEQUENTLY, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR DAYS AFTER A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2010, USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PATIENT EXPERIENCED RECTAL PAIN, AND THE PHYSICIAN NOTED "HARDNESS" WHEN THE PATIENT'S RECTUM WAS PALPATED. THE PHYSICIAN OPINED THAT THE PATIENT'S PAIN IS NOT ATTRIBUTABLE TO THE UPHOLD DEVICE. SHE IS BEING TREATED FOR THE PAIN WITH THE NARCOTIC DEMEROL, AND WITH IBUPROFEN. NO FURTHER MEDICAL INTERVENTION IS PLANNED. THE PHYSICIAN HAD PRESCRIBED THE ANTIBIOTICS FLAGYL AND LEVAQUIN PROPHYLACTICALLY, FOR A DURATION OF "A FEW WEEKS. HE STATED HE WAS "NOT SURE," BUT THE PATIENT "PROBABLY" DID NOT HAVE AN INFECTION. THE PATIENT REPORTEDLY RETURNED FOR A ONE-WEEK POST-PROCEDURE CHECK-UP, WHERE THE PHYSICIAN NOTED THAT WHILE THE PATIENT WAS STILL "A LITTLE SENSITIVE" AND HAD SOME DIFFICULTY SITTING ON HER BUTTOCKS, SHE WAS "MUCH BETTER" AND "FINE." THE PHYSICIAN PERFORMED A VAGINAL EXAM AND NOTED THAT THE SUTURE LINE LOOKED "FINE." HE ALSO PERFORMED A RECTAL EXAM, AND FELT A "TIGHT RIDGE" WHICH HE STATED WAS "DEFINITELY NOT TISSUE" AND WAS INSTEAD LIKELY TO BE "SOME CONTRACTURE OF THE MESH." HE STATED IT HAD "CONTRACTED PROBABLY MORE THAN I WANTED, [IT] DIDN'T SEEM TIGHT WHEN I CLOSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention