BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROTOMY SPONGE

    MDR report key: 6424346 · Received March 22, 2017

    Report

    Report Number
    2320762-2017-00004
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    February 22, 2017
    Report Date
    February 23, 2018
    Manufacturer
    GALIA TEXTILE S.A. DE C.V.
    Product Code
    GDY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT THE STRING OF A LAPAROTOMY SPONGE (FINISHED GOOD 1-1818) SEPARATED FROM THE SPONGE WHILE REMOVING THE SPONGE FROM A PATIENT DURING SURGERY. THE DEFECTIVE SAMPLE INITIALLY WAS REPORTED TO BE AVAILABLE FOR EVALUATION. AS OF THE DATE OF THIS REPORT, THAT SAMPLE HAS NOT BEEN RETURNED. RAW MATERIAL INVENTORY OF THE LAP SPONGE WAS CHECKED AND NO NON-CONFORMING PRODUCT WAS FOUND. THE WORK ORDER FOR THE REPORTED LOT WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE RAW MATERIAL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO (B)(4). A RESPONSE IS DUE APRIL 7, 2017. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE STRING TO THE LAP SPONGE HAS BEEN BREAKING OFF FROM THE SPONGE DURING THE REMOVAL OF THE SPONGE FROM THE PATIENT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208982 LAPAROTOMY SPONGE GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY GALIA TEXTILE S.A. DE C.V. 1-1818 42523926

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown