BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELPORT XE 120MM W/ALEXIS WOUND RETRACTOR

    MDR report key: 957404 · Received December 4, 2007

    Report

    Report Number
    2027111-2007-00086
    Event Type
    Other
    Date Received
    December 4, 2007
    Date of Event
    February 22, 2007
    Report Date
    November 9, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GAD
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 1 GELPORT CAP ASSEMBLY WAS RETURNED USED. UPON VISUAL INSPECTION, THE KRATON RING CONTAINED WITHIN THE ASSEMBLY WAS BROKEN. THE SHOP ORDER WAS REVIEWED AND CONTAINED NO TEMPORARY REDLINE CHANGES, MRR'S (MATERIAL REVIEW REQUESTS), OR REPAIR LOG REJECTIONS RELATIVE TO THE REPORTED INCIDENT. CONCLUSION: IT'S NOT KNOWN IF THE CRACK WAS PRESENT BEFORE USE. IT APPEARS THAT THE USER MAY HAVE APPLIED EXCESSIVE FORCE TO THE CAP ASSEMBLY WHEN SNAPPING IT ONTO THE AB BASE AND THE ALEXIS WOUND RETRACTOR. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    "CASE HAD BEEN RUNNING FOR 2 HOURS - SURGEON REINSERTED HAND AND THE PLASTIC RING ON GELPORT (THE FUSED PLASTIC ON GEL) SPLIT APART." PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELPORT XE 120MM W/ALEXIS WOUND RETRACTOR NONE GAD APPLIED MEDICAL RESOURCES CORP. C8105 1027951

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other