BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1871440 · Received October 15, 2010

    Report

    Report Number
    3005099803-2010-04408
    Event Type
    Injury
    Date Received
    October 15, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    'DESCRIBE EVENT OR PROBLEM', 'ADVERSE EVENT OR PRODUCT PROBLEM', AND 'OUTCOMES ATTRIBUTED TO ADVERSE EVENT' FIELDS UPDATED WITH CORRECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PELVIC FLOOR REPAIR PROCEDURE (PROCEDURE DATE UNKNOWN) USING A PELVIC FLOOR REPAIR KIT (EXACT TYPE UNKNOWN), THE PHYSICIAN HAD "2 OR 3 OCCASIONS [WHERE] ONE OF THE MESH ARMS BROKE." THE PHYSICIAN STATED THAT HE COULD FIND THE END OF THE AFFECTED MESH LEG, BUT HAD A "LITTLE BIT OF A STRUGGLE." IT IS UNKNOWN IF THE MESH ARMS BROKE AND FELL INSIDE THE PATIENT. NO FURTHER INFORMATION REGARDING THE EVENT, THE PATIENT, OR THE PROCEDURE HAS BEEN FORTHCOMING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PHYSICIAN "[WENT] BACK AND KIND OF [FOUND] THE END OF [THE MESH ARM]". BASED ON THIS REPORTED INFORMATION, INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R