BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATWING RETRACTOR

    MDR report key: 1060205 · Received June 6, 2008

    Report

    Report Number
    2249697-2008-00155
    Event Type
    Injury
    Date Received
    June 6, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    GAD
    PMA / PMN Number
    unk
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, AS NO ADD'L INFO REGARDING CATALOG NUMBER OR LOT CODE WAS MADE AVAILABLE. THE DEVICE WAS NOT RETURNED, AND X-RAYS WERE NOT PROVIDED. THE GLOBAL ITEM MASTER WAS QUERIED FOR DEVICES WITH "WING" IN THE DESCRIPTION FIELD. THE FOLLOWING DEVICES WERE FOUND: DESCRIPTION, WING RETRACTOR IMPACTOR/EXTRACTOR, CAT # 2153-2000. RETRACTOR LT, CAT #:2152-00L, RETRACTOR RT, CAT # 2152-00R. A REVIEW OF THE COMPLAINT HISTORY FOR THESE DEVICES FOUND THAT NO SIMILAR EVENTS REPORTED FOR THESE DEVICES. REPORTS HAVE BEEN RECEIVED THAT DESCRIBE BENDING OF THE TIPS OF THE 2152-00L AND 2152-00R INSTRUMENTS. IF ADD'L INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BATWING RETRACTOR INSTRUMENT GAD STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1