BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG

    MDR report key: 1182243 · Received June 10, 2008

    Report

    Report Number
    2027111-2008-00032
    Event Type
    Other
    Date Received
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    HOSP REPORTED DIRECT TO FDA AND DID NOT NOTIFY APPLIED MEDICAL. WE ARE REQUESTING THE HOSP RETURN THE EVENT SAMPLE FOR EVAL, AND WE WILL PROVIDE THE FDA WITH A F/U AS INFO BECOMES AVAILABLE. IN 2007, 11 UNITS SOLD RESULTED IN MDRS FOR "BURST BAG". FOR Q1 2008, 3 UNITS SOLD RESULTED IN THE SAME MDR. MOST OF THE FAILURES WERE ATTRIBUTED TO USERS ATTEMPTING TO EXTRACT THE FILLED BAG THROUGH AN UNDERSIZED INCISION. THE PROD INFO DATA SHEET SPECIFICALLY PRESCRIBES THAT, UNDER THESE CONDITIONS, THE INCISION MUST BE ENLARGED. THIS IS STANDARD PROCEDURE THAT REQUIRES JUDGMENT ON THE PART OF THE PRACTITIONERS, MOST OF WHOM ADJUST APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG * GCJ APPLIED MEDICAL RESOURCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization