BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN PAL STIRRUP

    MDR report key: 2196140 · Received July 20, 2011

    Report

    Report Number
    1221538-2011-00012
    Event Type
    Other
    Date Received
    July 20, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STIRRUP WAS NOT BEEN RETURNED FOR EVAL. ALLEN ATTEMPTED TO CONTACT THE REPORTER WHO DID NOT RETURN OUR CALLS. IT IS NOT CLEAR THAT THE STIRRUP MALFUNCTIONED IN ANY WAY. THE PT'S LEG COMING FREE FROM THE STIRRUP BOOT COULD HAVE RESULTED FROM IMPROPER POSITIONING, FAILURE TO PROPERLY AFFIX THE VELCRO ON THE BOOT PAD AND INSUFFICIENT FIXATION ON THE BOOT MOUNT HANDLE. A REVIEW OF REPAIR RECORDS INDICATES THERE IS NO RECORD OF THIS 8-YEAR-OLD STIRRUP EVER HAVING BEEN SENT IN FOR EVAL OR REPAIR. SHOULD THE STIRRUP BE RETURNED FOR EVAL, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ALLEN RECEIVED A COPY OF A VOLUNTARY MEDWATCH REPORT (B)(4) FROM THE FDA. IT WAS FILED (B)(6) 2011 BY (B)(6). THE NON-INJURY INCIDENT DESCRIBED IN THE REPORT WAS SAID TO HAVE TAKEN PLACE ON (B)(6) 2011. IT WAS NOT REPORTED TO (B)(4) AT THE TIME OF THE INCIDENT. ACCORDING TO THE HOSP REPORTER, AT THE END OF A PROCEDURE, THE DRAPE WAS REMOVED TO FIND THE PT'S RIGHT LEG WAS "ACUTELY BENT" AND OUT OF THE BOOT. THERE IS NO MENTION IN THE REPORT OF HOW OFTEN THE STAFF HAD CHECKED ON THE PT DURING THE CASE - AN INDICATOR OF DURATION FOR THIS POSITION. NO INJURIES OR COMPLICATIONS WERE SAID TO HAVE RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN PAL STIRRUP POWER ASSISTED LITHOTOMY STIRRUPS FWZ ALLEN MEDICAL SYSTEMS A-10023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK