BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE

    MDR report key: 15672466 · Received October 26, 2022

    Report

    Report Number
    3007305485-2022-00164
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    October 11, 2022
    Report Date
    December 7, 2022
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    FZQ
    UDI-DI
    10653405050605
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODE: QQS. MANUFACTURER NARRATIVE: THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT BEING RETURNED AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. IN ADDITION, THE INFORMATION FROM THE CUSTOMER INDICATED THE DEVICE WAS MISUSED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THE REFLEX® ONE AND REFLEX® TL SKIN STAPLERS SHOULD BE USED ONLY BY PERSONNEL WITH ADEQUATE TRAINING AND KNOWLEDGE OF SKIN CLOSURE PROCEDURES. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE WAS BEING USED ON APPROXIMATELY ON (B)(6) 2022 AND THE ¿STAPLES DO NOT COME OUT PROPERLY, SO THE ADHESION OF THE SKIN DOES NOT HOLD." THE PROCEDURE WAS NOT COMPLETED AND ¿WOULD HEALING DISRUPTED¿. AFTER FURTHER ASSESSMENT IT WAS DISCOVERED THAT THE CUSTOMER CONFIRMED IT WAS JUST THE WRONG SIZE OF STAPLE AS THEY ARE USED TO. IT WAS ACTUALLY DOWN TO THE WAY THEY USED THE ARTICLE. NOTHING OF COMPLAINT IN TERMS OF THE ARTICLE. NO OTHER INFORMATION WAS RECEIVED, SO IT IS UNKNOWN IF THE PATIENT RECEIVED TREATMENT OR THE PATIENT'S CURRENT CONDITION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO WOUND HEALING DISRUPTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE WAS BEING USED ON APPROXIMATELY (B)(6) 2022 AND THE ¿STAPLES DO NOT COME OUT PROPERLY, SO THE ADHESION OF THE SKIN DOES NOT HOLD.¿. THE PROCEDURE WAS NOT COMPLETED AND ¿WOULD HEALING DISRUPTED¿. AFTER FURTHER ASSESSMENT IT WAS DISCOVERED THAT THE CUSTOMER CONFIRMED IT WAS JUST THE WRONG SIZE OF STAPLE AS THEY ARE USED TO. IT WAS ACTUALLY DOWN TO THE WAY THEY USED THE ARTICLE. NOTHING OF COMPLAINT IN TERMS OF THE ARTICLE. NO OTHER INFORMATION WAS RECEIVED, SO IT IS UNKNOWN IF THE PATIENT RECEIVED TREATMENT OR THE PATIENT'S CURRENT CONDITION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO WOUND HEALING DISRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509245 REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE CLIP, REMOVABLE (SKIN) FZQ CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202205314 10653405050605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other