BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMUS (THE BTE WS30)

    MDR report key: 2625719 · Received June 18, 2012

    Report

    Report Number
    1119903-2012-00001
    Event Type
    Other
    Date Received
    June 18, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 23, 2012
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    ISD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONCE BTE PERSONNEL BECAME AWARE OF THE INCIDENT IT WAS PROMPTLY REVIEWED, EVALUATED, AND INVESTIGATED. BTE PERSONNEL SPOKE WITH THE CLINIC AND THE DEVICE DISTRIBUTOR STAFF SEVERAL TIMES TO INQUIRE ABOUT THE PT'S STATUS. THE PT REC'D THREE (3) STITCHES ON THE FOREHEAD, DID NOT SEEK ANY ADD'L MEDICAL ATTENTION AND RETURNED TO THE SAME CLINIC TO CONTINUE THERAPY. BASED ON THE INFO OBTAINED, AND AS UNFORTUNATE AS THIS EVENT WAS, AN IN VIEW OF THE DEFINITION OF SERIOUS INJURY, WE DID NOT DEEM THAT THIS MET THE REPORTING REQUIREMENTS. IT WAS CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION. IN SUMMARY, THE QUALITY MANAGER BELIEVED THAT NONE OF THE CRITERIA FOR SUBMITTING A 30 DAY REPORT HAD BEEN MET: IT WAS NOT A SERIOUS INJURY AND THE DEVICE DID NOT MALFUNCTION. CONSEQUENTLY, THE DECISION NOT TO FILE A REPORT WITH THE FDA WAS MADE.

    Description of Event or Problem · 1

    THE PT WAS INJURED USING AN ATTACHMENT (TOOL 901) DURING A SHOVEL EXERCISE DUE TO A REPORTED SUDDEN LOSS OF RESISTANCE. THE EXERCISE WAS CONDUCTED AS PART OF THERAPY FOR RUPTURE OF THE ACL, RIGHT SIDE. THE PT HEAD CAME IN CONTACT WITH THE LEVER ARM OF THE TOOL. THE PT REC'D THREE (3) STITCHES ON THE FOREHEAD. HOSPITALIZATION WAS NOT REQUIRED AND THE INDIVIDUAL INVOLVED RETURNED TO CONTINUE TREATMENT AT THE CLINIC. HIS TREATMENT DATES ARE FROM (B)(6) 2012, SEVERAL TIMES PER WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMUS (THE BTE WS30) PRIMUS ISD BTE TECHNOLOGIES, INC. PRIMUSRS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other