BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORCO SHOULDER PULLEY

    MDR report key: 2504738 · Received March 23, 2012

    Report

    Report Number
    2939821-2011-00016
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    May 30, 2011
    Report Date
    March 21, 2012
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    ION
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, CUSTOMER WAS REHABILITATING HIS LEFT SHOULDER, WHICH HAD RECENTLY UNDERGONE SURGERY, USING A NORCO SHOULDER PULLEY GIVEN TO HIM BY HIS TREATING PHYSICIAN. THE PULLEY'S WHEEL SNAPPED, CAUSING THE CUSTOMER TO SUSTAIN INJURY. ON (B)(6) 2011, THE CUSTOMER PRESENTED TO AN ORTHOPEDIC PRACTICE CENTER. PHYSICIAN'S ASSISTANT NOTED THAT THE CUSTOMER WAS WORKING OUT WITH HIS PULLEY TO MAINTAIN RANGE OF MOTION AFTER UNDERGOING A LEFT SHOULDER ARTHROPLASTY, WHEN THE PULLEY BROKE, CAUSING A FORCED EXTENSION INJURY TO THE RIGHT SHOULDER. X-RAYS OF THE RIGHT SHOULDER REVEALED A MASSIVE, UNREPAIRABLE ROTATOR CUFF TEAR AND SPONTANEOUS RUPTURE OF THE BICEPS TENDON. A GLENOHUMERAL JOINT INJECTION WAS ADMINISTERED FOR PAIN. ON (B)(6) 2011, THE CUSTOMER PRESENTED TO THE SAME ORTHOPEDIC PRACTICE CENTER. THE SAME PHYSICIAN'S ASSISTANT NOTED THAT THE CUSTOMER DECLINED SURGERY ON THE RIGHT SHOULDER, SO A GLENOHUMERAL JOINT INJECTION WAS ADMINISTERED. ON (B)(6) 2011, THE CUSTOMER PRESENTED TO THE SAME ORTHOPEDIC PRACTICE CENTER. PHYSICIAN'S ASSISTANT NOTED THAT THE CUSTOMER UNDERWENT A REPEAT INJECTION OF THE RIGHT SHOULDER, AND THAT HE WAS MARKEDLY DEBILITATED FROM HIS INJURY REGARDING THE PULLEY. THE CUSTOMER'S TREATING PHYSICIAN HAS PROVIDED A CAUSATION LETTER DOCUMENTING THAT HE HAS A PROBABLE CUFF TEAR WHICH PRESENTLY LEAVES HIS ARM FUNCTIONALLY WORTHLESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORCO SHOULDER PULLEY SHOULDER PULLEY ION NORTH COAST MEDICAL, INC. NC52069 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other