BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLASSMAN VISCERA RETAINER

    MDR report key: 6236863 · Received January 10, 2017

    Report

    Report Number
    2918699-2017-70001
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    November 16, 2016
    Report Date
    January 5, 2017
    Manufacturer
    ADEPT-MED INTERNATIONAL, INC.
    Product Code
    GCZ
    PMA / PMN Number
    K802806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING PHYSICIAN STATES : HE HAS UTILIZED A GLASSMAN VISCERA RETAINER, FISH AT LEAST 500 TIMES IN THE PAST WITHOUT INCIDENT. NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    RECEIVED A TELEPHONE CALL FROM REPORTING PARTY ON 12/08/2016 WHO RELAYED THE FOLLOWING INFORMATION : ON (B)(6) 2016, J. DOE HAD A SURGICAL PROCEDURE THAT REQUIRED A LARGE ABDOMINAL INCISION. A GLASSMAN VISCERA RETAINER, SIZE MEDIUM, ITEM# 3204 WAS USED IN THE CLOSURE. J. DOE DID WELL AFTER SURGERY. ON (B)(6) 2016, J. DOE WAS TAKEN FOR AN X-RAY, UNRELATED TO THE ORIGINAL SURGERY AND A GLASSMAN VISCERA RETAINER RADIOPAQUE STRIP WAS VISIBLE IN THE X-RAY AND IDENTIFIED AS A RETAINED FOREIGN OBJECT. J. DOE WAS TAKEN TO SURGERY ON THAT SAME DAY, 2 SKIN SUTURES AND 1 FACIAL SUTURE FROM THE ORIGINAL SURGERY WERE REMOVED AND THE GLASSMAN VISCERA RETAINER WAS REMOVED WITHOUT INCIDENT. REPORTING PARTY STATES THE 2ND SURGERY WAS COMPLETED IN 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20189 GLASSMAN VISCERA RETAINER VISCERA RETAINER, FISH ® GCZ ADEPT-MED INTERNATIONAL, INC. 3204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention