BEUDAMED
    FDA Adverse Event Other Summary report: N

    "ALLEN STIRRUPS"

    MDR report key: 2027917 · Received February 11, 2011

    Report

    Report Number
    1221538-2011-00005
    Event Type
    Other
    Date Received
    February 11, 2011
    Date of Event
    August 10, 2009
    Report Date
    January 14, 2011
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT SAID THAT SHE WAS TREATED BY THE HOSPITAL FOR A PROLONGED HYSTERECTOMY CASE (SCHEDULED FOR 2.5 HOURS BUT WHICH STRETCHED TO 5.5 HOURS) DURING WHICH - SHE WAS TOLD, HER FOOT CAME FREE FROM AN ALLEN STIRRUP WHILE ANESTHETIZED. SHE REPORTEDLY SUSTAINED SERIOUS INJURIES INCLUDING TORN CARTILAGE IN HER HIP AND IS STILL UNDERGOING TREATMENT FOR PAIN AND MOBILITY. THERE WAS NOT A REPORT OF THE INCIDENT SHARED WITH ALLEN MEDICAL FROM THE HOSPITAL AT THE TIME OF THE INCIDENT. THE HOSPITAL RISK MGMT DEPT CONFIRMED THEY HAVE BEEN NOTIFIED OF THE PT LAWSUIT. THERE WAS NO ADD'L INFO AVAILABLE AND ALLEN WAS UNABLE TO DETERMINE IF ANY OF OUR PRODUCTS WAS ACTUALLY USED OR PLAYED A ROLE IN THE INCIDENT. IF ANY NEW SUBSTANTIVE INFO IS PROVIDED ABOUT THE DEVICE OR THIS CLAIM IT WILL BE MADE IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6), 2011, AN INDIVIDUAL IDENTIFYING HERSELF AS A FORMER PT OF (B)(6) MEDICAL OF (B)(6) CALLED ALLEN MEDICAL SEEKING INFO ON OUR PRODUCTS AND THEIR USE. THE REPORTER STATED SHE WAS PURSUING LEGAL ACTION (B)(6) THE HOSPITAL FOR AN INCIDENT THAT HAS LEFT HER IN CHRONIC PAIN AND PARTIALLY DISABLED. ALLEN STIRRUPS WERE REPORTEDLY USED - ACCORDING TO WHAT THE HOSPITAL TOLD HER, SHE SAID. BUT SHE DID NOT EVER SEE THE PRODUCT, NOR WAS IT EVER IDENTIFIED FOR HER, SHE ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "ALLEN STIRRUPS" "ALLEN STIRRUPS" FWZ ALLEN MEDICAL SYSTEMS UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability