BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 REGULAR

    MDR report key: 3013179 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01325
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE ADDITIONAL INFORMATION RECEIVED AND REVIEW BY THE COMPANY MEDICAL DIRECTOR IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: HOW LONG AFTER THE STAPLES WERE PLACED WAS THE GAP FOUND? POST-OP CHECK AND TO HAVE THE STAPLES EXTRACTED AT DAY 5. THEN THE GAP IS EVIDENT. THE LOWER EDGE HAS GONE DOWN (AWAY) AND THE UPPER FLAPPED OVER THE LOWER. WAS THERE ANY ISSUE WITH INFECTION? NO ISSUES WITH INFECTION HAS BEEN REPORTED ADJACENT TO THE ISSUE WITH STAPLES. WHAT TYPE OF C-SECTION? VERTICAL-HORIZONTAL VERTICAL C-SECTIONS. HOW WERE THE LAYERS BENEATH THE STAPLE LINE CLOSED? FIRST THE FASCIA IS SUTURED AND THEN THE SUB CUTIS IF IT IS MORE THAN 2CM (ALMOST ALWAYS) AND THEN THE SKIN IS STAPLED. HOW IS THE SCAR BEING ADDRESSED? THEY HAVE USED A SILVER NITRATE PIN FOR EDGE CLOSURE. STILL THERE HAS NOT BEEN A REQUEST FOR A REVISION ON THE SCAR.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED INDICATES THAT THERE WAS NO DEFICIENCY AT THE TIME WHEN THE STAPLING WAS DONE. THE CLINIC HAS REALIZED THAT THEY PROBABLY MADE THE MISTAKE THEMSELVES AND REMOVED THE STAPLES TOO SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEONS SAW A GAP WHILE STAPLING, DURING CAESAREAN SECTION CLOSURE. DURING A FOLLOW UP VISIT, THE INCISIONS HAD NOT GROWN AS EXPECTED. THE MIDWIFE AND SURGEON DESCRIBED THE STAPLES DID NOT GET A GOOD GRIP IN THE SKIN AS THEY WERE SUPPOSED TO. DURING FOLLOW UP VISIT, THAT THE LOWER EDGE HAS GONE DOWN (AWAY) AND THE UPPER FLAPPED OVER THE LOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115313 PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 REGULAR REMOVABLE (SKIN) GDT ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other