BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN PRONE ARM SUPPORT

    MDR report key: 1966971 · Received January 14, 2011

    Report

    Report Number
    1221538-2011-00004
    Event Type
    Other
    Date Received
    January 14, 2011
    Report Date
    December 17, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEN REP EVALUATED THE PRODUCT IN THE FIELD AND FOUND NO ISSUE WITH ITS FUNCTION OR SAFETY. THE REP RE-INSERVICED THE STAFF ON THE PROPER USE OF THE DEVICE. FOLLOWING TREATMENT, THE PATIENT RECOVERED FULLY, THE STAFF SAID. NO NEW PROBLEMS HAVE BEEN REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    AN ALLEN REP WAS CONTACTED BY A SURGEON AT (B)(6) REQUESTING A SITE VISIT/TRAINING FOLLOWING A POST-OPERATIVE NERVE DEFICIT EXPERIENCED BY ONE OF HIS PATIENTS FOLLOWING A PRONE POSITIONING CASE. DURING THE CASE, ALLEN PRONE ARM SUPPORTS WERE USED. THE SEVERITY OF THE CONDITION WAS NOT KNOWN BUT THE HOSPITAL STAFF REPORTED, THE PATIENT HAS COMPLETELY RECOVERED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN PRONE ARM SUPPORT PRONE ARM SUPPORT FWZ ALLEN MEDICAL SYSTEMS A-70610-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other