BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNAPP KNEE ORTHOSIS

    MDR report key: 1221843 · Received October 31, 2008

    Report

    Report Number
    2031466-2008-00001
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 27, 2008
    Manufacturer
    HELY & WEBER
    Product Code
    IQI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION WAS PERFORMED ON BRACE BECAUSE THE BRACE WAS NOT RETURNED. INVESTIGATION SHOWED THAT DEVICE FAILURE WAS NOT RELEVANT TO PATIENT'S CONDITION, SO NO DEVICES FROM INVENTORY WERE EVALUATED. HELY & WEBER HAS MANUFACTURED THIS PRODUCT FOR MORE THAN 12 YEARS WITH TOTAL UNITS SOLD AND HAS NEVER RECEIVED AN ADVERSE EVENT REPORT FROM THE FDA TO DATE; FOR ANY OF ITS PRODUCTS. THERE IS THE OCCASIONAL REPORT FROM DOCTORS OR END USERS OF MINOR ALLERGIC REACTION BUT NEVER TO THIS DEGREE. THE INSTRUCTION FOR USE STATE THAT IF SKIN IRRITATION DEVELOPS, TO REMOVE THE BRACE IMMEDIATELY AND CONSULT THE PRESCRIBING PRACTITIONER. AFTER RESEARCH OF STEVENS JOHNSON SYNDROME OVER THE INTERNET WITH THE MAYO CLINIC AND OTHER ARTICLES WE HAVE DETERMINED THIS IS AN EXTREMELY RARE CONDITION THAT AFFECTS 2-3 PER MILLION PERSONS. STEVENS JOHNSON SYNDROME USUALLY RESULTS FROM A DRUG REACTION. DUE TO THE FACT THAT WE HAVE SOLD THIS PRODUCT FOR MORE THAN 12 YEARS WITH NO SIMILAR SITUATION AS THIS, WE FEEL THAT WE DO NOT HAVE A SERIOUS CONDITION THAT WILL WARRANT FURTHER ACTION AT THIS TIME. WE HAVE IN PLACE A POST MARKET SURVEILLANCE SOP THAT LOGS ALL PRODUCT COMPLAINTS OF THIS NATURE AND WILL CONTINUE TO MONITOR OUR PRODUCTS FOR ANY UNUSUAL SIMILAR ACTIVITY.

    Description of Event or Problem · 1

    PATIENT WAS GIVEN NEOPRENE KNEE BRACE. WITHIN 3 DAYS PATIENT DEVELOPED WHAT APPEARED TO BE A RASH OR CONTACT DERMATITIS. PATIENT WAS GIVEN MEDICATION (PREDINSONE) UPON WHICH REACTION (CONTACT DERMITITIS) SUBSIDED. PATIENT CONTINUED TO WEAR KNEE BRACE DURING MEDICATION. AFTER FINISHING MEDICATION, CONTACT DERMITITIS REAPPEARED AND PATIENT CONTINUED TO WEAR KNEE BRACE, AND WAS GIVEN PREDINSONE AGAIN. RASH SUBSIDED BUT REAPPEARED AGAIN. KNEE BRACE WAS THEN REMOVED FROM PATIENT, BUT THE CONTACT DERMATITIS DEVELOPED INTO ASEPTIC NECROSIS. ADVERSE EVENT REPORT WAS FILED BY THE PATIENT WITH THE FDA ON SEPTEMBER 24TH. RECEIVED AT HELY AND WEBER ON OCTOBER 20. CONTACT WAS MADE WITH PATIENT'S WIFE ON THE FOLLOWING MONTH. PATIENT'S WIFE SAID THAT HIS CONDITION HAD DEVELOPED INTO STEVENS JOHNSON SYNDROME AS A RESULT OF THE MEDICATION GIVEN TO HIM. SHE SAID SHE DID NOT FEEL THE BRACE WAS THE REASON FOR THE STEVENS JOHNSON SYNDROME. SHE ALSO MENTIONED THAT HE HAD WORN A NEOPRENE KNEE BRACE IN THE PAST FOR ANOTHER KNEE INJURY PRIOR TO THIS INCIDENT WITH NO REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNAPP KNEE ORTHOSIS KNEE ORTHOSIS IQI HELY & WEBER 5656 25651

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PREDNISONE