BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PLUS WIDE SKIN STAPLER

    MDR report key: 41088 · Received September 13, 1996

    Report

    Report Number
    8022156-1996-00002
    Event Type
    Malfunction
    Date Received
    September 13, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 13, 1996
    Manufacturer
    J & J MEDICAL PRODUCTS
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A1,2,3,4;B6,7;D10: INFORMATION UNAVAILABLE: D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ON 8/16/96 CONTACT PERSON CALLED THE CIN DIRECTLY AND STATED THE SURGEON HAD USED THE SKIN STAPLER TO AFFLIX MESH DURING A HERNIA REPAIR. APPROXIMATELY THREE HOURS POST-OP, THE PATIENT'S SCROTUM WAS ENLARGED AND THE PATIENT WAS RETURNED TO THE OR HOLDING AREA FOR OBSERVATION FOR QUESTIONABLE BLEEDING. THE PATIENT REPORTEDLY DID NOT REQUIRE ANY TREATMENT, HOWEVER, AND THE SWELLING RESOLVED. TSB 8/21/96 WAS ABLE TO TALK TO THE OR NURSE, REGARDING THIS CASE, DR ELECTED TO USE THE SKIN STAPLER FOR ATTACHMENT OF MESH DURING A HERNIA REPAIR, DESPITE THE FACT THAT HE WAS WELL THAT THIS WAS CONTRARY TO THE LABELING. 8/21/96 THE PATIENT SUSTAINED SOME BLEEDING POST OPERATIVELY AND WAS OBSERVED IN THE RECOVERY ROOM. REEXPLORATION WAS NOT CARRIED OUT. ATTEMPTED TO REACH DR AND HAVE NOT MADE CONTACT. 8/26/96 1535 SPOKE TO CONTACT IN SAFETY WHO REFERRED ME TO CONTACT IN BIO-MED. AND SHE SAID ANOTHER PERSON WILL CALL BACK. TKB

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PLUS WIDE SKIN STAPLER SKIN STAPLER GDT J & J MEDICAL PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other