BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 3608591 · Received January 23, 2014

    Report

    Report Number
    2320762-2014-00001
    Event Type
    Injury
    Date Received
    January 23, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 20, 2013
    Manufacturer
    G.A. SURGICAL (PVT) LTD
    Product Code
    FHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE MEDICAL CENTER REPORTED THAT THE GOMCO BELLS SEEM TO BE DEFECTIVE. THEY HAVE BEEN EXPERIENCING AN INCREASE IN NEWBORNS BLEEDING POST CIRCUMCISION BECAUSE THE BELL DOES NOT CLAMP PROPERLY. DEROYAL: THE SUPPLIER'S INVESTIGATION DETERMINED THAT LOTS WERE BUILT OUT OF SPECIFICATION, RESULTING IN THE POTENTIAL FOR THE DEVICE TO NOT CLAMP THE SURGICAL SITE PROPERLY. DEROYAL HAD MADE A ONE TIME PURCHASE FROM (B)(4) AND HAS DETERMINED TO CONDUCT A VOLUNTARY RECALL OF ALL PRODUCTS PURCHASED FROM THEM. ANY PRODUCT REMAINING IN INVENTORY HAS BEEN QUARANTINED FOR DESTRUCTION, AND INITIAL RECALL LETTERS HAVE BEEN SENT TO AFFECTED CUSTOMERS.

    Description of Event or Problem · 1

    THE MEDICAL CENTER REPORTED THAT THE GOMCO BELLS SEEM TO BE DEFECTIVE. THEY HAVE BEEN EXPERIENCING AN INCREASE IN NEWBORNS BLEEDING POST CIRCUMCISION BECAUSE THE BELL DOES NOT CLAMP PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54655 DEROYAL FHA - CLAMP, PENILE FHA G.A. SURGICAL (PVT) LTD 33444071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other