BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARMBOARD

    MDR report key: 1812819 · Received May 18, 2010

    Report

    Report Number
    1221538-2010-00002
    Event Type
    Other
    Date Received
    May 18, 2010
    Date of Event
    March 15, 2010
    Report Date
    April 21, 2010
    Manufacturer
    ALLEN MEDICAL
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON RECEIPT OF THE REPORT, ALLEN CONTACTED THE (B)(6) TO REQUEST ADDITIONAL INFO ABOUT THE REPORTER TO HELP US INVESTIGATE THE REPORTED INCIDENT AND TO EVALUATE THE PRODUCT CONDITION. THE FOLLOWING INFO WAS PROVIDED BY A (B)(6) REP: REPORTING FACILITY: (B)(6). THE NAME AND NUMBER PROVIDED TO (B)(6) IN THE REPORT DID NOT BELONG TO THE REPORTER, BUT A LAW OFFICE. THE TELEPHONE NUMBER PROVIDED BELONGS TO (B)(6) LAW OFFICE - WITH AN ADDRESS REGISTERED AT (B)(6)). THE REP WHO WE SPOKE TO THERE SAID THE STAFF HAD NO INFO REGARDING THE INCIDENT. NO FURTHER DETAILS ABOUT THE INCIDENT, DEVICE OR OUTCOME HAVE BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, ALLEN MEDICAL RECEIVED A COPY OF A VOLUNTARY MEDWATCH REPORT (B)(4) FILED WITH THE DEPT OF HEALTH AND HUMAN RESOURCES. PRIOR TO THE RECEIPT OF THIS FDA LETTER, THE INCIDENT SUBJECT TO THE REPORT HAD NOT BEEN REPORTED ALLEN. "PATIENT WAS IN A LEFT LATERAL POSITION FOR A PROCEDURE, WITH THE LEFT ARM SECURED TO THE ARMBOARD. AT SOME UNDETERMINED POINT IN THE PROCEDURE, THE ARMBOARD DETACHED FROM THE TABLE. THIS WAS NOTED AT THE END OF THE PROCEDURE WHILE THE DRAPES WERE BEING REMOVED. THE ARMBOARD WAS STILL ATTACHED THE PT'S ARM BY THE SOFT SAFETY STRAP. THE SAFETY STRAP CAUSED THE ARMBOARD TO REMAIN ATTACHED AND PULL THE ARM IN A DOWNWARD DIRECTION, HYPER EXTENDING THE ELBOW. NO BRUISING NOTED. SLIGHT AMOUNT OF REDNESS NOTED." THE USER FACILITY, SERIAL NUMBER OF THE DEVICE AND THE REPORTER'S NAME WERE NOT PROVIDED ON THE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1