BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN JOINT REPAIR DEV

    MDR report key: 14009174 · Received April 5, 2022

    Report

    Report Number
    1643264-2022-00119
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    September 30, 2021
    Report Date
    May 11, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LDQ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, AN INSTRUCTIONS FOR USE REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, A RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A REVIEW OF THE CUSTOMER PROVIDED IMAGES FOUND ONE IMAGE THAT APPEARS TO BE A BURN ON AN ARM, AND ANOTHER IMAGE THAT APPEARS TO BE A HEALED BURN ON AN ARM. THE TWO UNDATED, UNLABELED PHOTOS PROVIDED, SHOWS A THERMAL INJURY. HOWEVER, THE INFORMATION PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THE PATIENT¿S SYMPTOMS, SIGNS OR OUTCOME ARE DUE TO A PRE-EXISTING OR CONCURRENT MEDICAL OR SURGICAL CONDITION OR PROCEDURE, OR TO AN ADVERSE REACTION TO OR EXPERIENCE WITH THE DEVICE, ONE OR MORE OF ITS COMPONENTS, OR ITS INTENDED THERAPEUTIC ACTION. THEREFORE, THE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS ALREADY BEEN REPORTED CANNOT BE CONFIRMED NOR CONCLUDED. SHOULD ANY ADDITIONAL RELEVANT MEDICAL INFORMATION BE PROVIDED, THIS CASE WOULD BE RE-ASSESSED. THE COMPLAINT WAS CONFIRMED, BUT THE ROOT CAUSE COULD NOT BE ESTABLISHED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE A FAILURE OF A CONCOMITANT DEVICE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER SURGERY. AFTER DISCHARGE FROM THE HOSPITAL, THE PATIENT DISCOVERED A BURN ON THE ARM OPPOSITE AT THE OPERATED ONE, ON THE BACK OF THE FOREARM. THE PATIENT CLAIMS THAT THE CAUSE OF THE DAMAGE COULD BE THE EQUIPMENT USED DURING THE OPERATION. IT IS UNKNOWN HOW WAS THE BURN TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78009 UNKNOWN JOINT REPAIR DEV DEVICE, GENERAL MEDICAL LDQ SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other