BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOEMIC, 20 MM

    MDR report key: 4148017 · Received October 7, 2014

    Report

    Report Number
    1220246-2014-00183
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWD
    PMA / PMN Number
    K063058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT PART REMAINS IN THE PATIENT AND CANNOT BE RETURNED THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF ADVERSE EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PART REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RASH WAS FIRST NOTED ON THE PATIENT'S FOOT NEAR THE IMPLANTS ON BOTH TOES AND UNDER THE FOOT. THE RASH THEN TRAVELED TO BOTH HER HANDS. FOLLOW-UP INFORMATION: THE PATIENT IS HAVING A REACTION AFTER AN ANATOMIC PROCEDURE OF THE 2ND AND 3RD TOES OF HER LEFT FOOT. A RASH WAS FIRST NOTED ON THE PATIENT'S FOOT NEAR THE IMPLANTS ON BOTH TOES AND UNDER THE FOOT. THE BLISTERING RASH THEN TRAVELED TO BOTH OF HER HANDS AND WRIST. THE AREAS OF THE RASH ARE RED, PAINFUL AND SWOLLEN. THE PATIENT HAD A BASIC ALLERGY TEST DONE AND WAS NEGATIVE. SHE WILL NOW HAVE A HEAVY METAL PATCH TEST PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629344 ANATOEMIC, 20 MM PROSTHESIS, TOE, HEMI-, PHALANGEAL KWD ARTHREX, INC. 1248011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other