BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3242214 · Received July 23, 2013

    Report

    Report Number
    2520274-2013-04548
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 510K#: DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON A CANINE, THE TRIGGER OF THE SMALL BATTERY DRIVE WAS STICKING. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED APPROXIMATELY 45 MINUTES DUE TO A DEVICE ISSUE. A SPARE DEVICE WAS NOT AVAILABLE FOR USE. INSTEAD, THE SURGEON USED AN AIR DRIVE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. DATE OF EVENT REPORTED ONLY AS (B)(6) 2013. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344325 SMALL BATTERY DRIVE HWE GMBH 003526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention