BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN CONTOUR WINGSETS

    MDR report key: 1211630 · Received October 24, 2008

    Report

    Report Number
    1221538-2008-00009
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 22, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS REPORTED AS A RESULT OF THE PATIENT OUTCOME, AND DID NOT INCLUDE A CLAIM OF DEVICE DEFICIENCY. THE DEVICE IN QUESTION IS AN ALLEN MEDICAL FIELD DEMONSTRATION UNIT. IT WAS REVIEWED VISUALLY BY A TRAINED COMPANY REPRESENTATIVE. NO DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    ON JULY 30, 2008, AN ALLEN REPRESENTATIVE WAS CONTACTED A SURGEON. DR. REPORTED THE SYMPTOMS OF A BRACHIAL NERVE INJURY IN ONE OF HIS PATIENTS FOLLOWING EIGHT-HOURS OF PRONE POSITIONING DURING A CASE. AT THAT TIME, THE DOCTOR INDICATED THE OUTCOME MAY HAVE RESULTED FROM THE STAFF'S POSITIONING TECHNIQUE. IN MID-AUGUST, DR. REPORTED THAT THE PATIENT APPEARED TO HAVE NO RESIDUAL NUMBNESS AND APPEARED TO BE MAKING A FULL RECOVERY. (FULL MOTOR SKILL RECOVERY AT THAT TIME.) BASED ON THESE COMMUNICATIONS, AN MDR REPORT WAS NOT REQUIRED. NEW INFORMATION WAS RECEIVED ON SEPTEMBER 29, WHICH REVEALED THAT THE PATIENT WAS AGAIN EXPERIENCING NUMBNESS AND PAIN IN THE UPPER EXTREMITY AS PER THE ORIGINAL REPORT. ADDITIONAL MEDICAL TREATMENT INCLUDING PAIN MANAGEMENT SESSIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN CONTOUR WINGSETS ALLEN CONTOUR FWZ ALLEN MEDICAL SYSTEMS A-70270-A1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability