BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE

    MDR report key: 19447222 · Received June 3, 2024

    Report

    Report Number
    3007305485-2024-00082
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 20, 2024
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    FZQ
    UDI-DI
    00653405037012
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. 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. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: WHEN IT IS NOT POSSIBLE TO MAINTAIN AT LEAST 5 MM DISTANCE FROM THE STAPLED SKIN TO UNDERLYING BONES, VESSELS, AND INTERNAL ORGANS, THE USE OF STAPLES FOR SKIN CLOSURE IS CONTRAINDICATED. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 8735, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE DEVICE WAS BEING USED DURING A SCALP LACERATION REPAIR ON (B)(6) 2024, AND ¿THE STAPLER DID NOT RELEASE ONCE IN THE PATIENT'S SCALP¿. THROUGH FOLLOW-UP ASSESSMENT, THE PHYSICIAN STATED: ¿I HAD TO REMOVE THE STAPLES THAT STUCK TO THE SCALP AND STAPLER BECAUSE THEY STAPLED TO HIGH ABOVE THE SCALP. I HAD TO TRIGGER THE STAPLER AGAIN TO RELEASE THE FIRST ONE AND THEN THE SECOND ONE DID THE SAME THING AND I HAD TO JIGGLE AND MOVE AROUND THE STAPLER TO RELEASE THE SECOND ONE. EVENTUALLY AFTER MANIPULATION AND MOVING AROUND THE STAPLER WHILE STILL IN THE SCALP IT RELEASED. OUT OF THE 4 THAT WAS DEPLOYED I HAD TO REMOVE 2 OF THEM BEFORE USING THE SMALLER STAPLER DEVICE¿. THE PHYSICIAN DESCRIBED AN OUTCOME OF INJURY DUE TO THE PATIENT HAVING "HAD MORE PAIN WITH MOVING AROUND THE STAPLER DEVICE STUCK TO THE SCALP. HE HAD SOME BLEEDING FROM THE MANIPULATION THAT WAS ABLE TO BE STOPPED WITH PRESSURE.". THERE WAS NO REPORTED DELAY AND NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE PATIENT¿S CONDITION IS ¿STABLE¿. THIS REPORT IS BEING RAISED ON THE BASIS OF THE REPORTED INJURY OF PAIN AND BLEEDING.

    Description of Event or Problem · 0

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 8735, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE DEVICE WAS BEING USED DURING A SCALP LACERATION REPAIR ON (B)(6) 2024, AND ¿THE STAPLER DID NOT RELEASE ONCE IN THE PATIENT'S SCALP¿. THROUGH FOLLOW-UP ASSESSMENT, THE PHYSICIAN STATED: ¿I HAD TO REMOVE THE STAPLES THAT STUCK TO THE SCALP AND STAPLER BECAUSE THEY STAPLED TOO HIGH ABOVE THE SCALP. I HAD TO TRIGGER THE STAPLER AGAIN TO RELEASE THE FIRST ONE AND THEN THE SECOND ONE DID THE SAME THING AND I HAD TO JIGGLE AND MOVE AROUND THE STAPLER TO RELEASE THE SECOND ONE. EVENTUALLY AFTER MANIPULATION AND MOVING AROUND THE STAPLER WHILE STILL IN THE SCALP IT RELEASED. OUT OF THE 4 THAT WAS DEPLOYED I HAD TO REMOVE 2 OF THEM BEFORE USING THE SMALLER STAPLER DEVICE¿. THE PHYSICIAN DESCRIBED AN OUTCOME OF INJURY DUE TO THE PATIENT HAVING "HAD MORE PAIN WITH MOVING AROUND THE STAPLER DEVICE STUCK TO THE SCALP. HE HAD SOME BLEEDING FROM THE MANIPULATION THAT WAS ABLE TO BE STOPPED WITH PRESSURE." THERE WAS NO REPORTED DELAY AND NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE PATIENT¿S CONDITION IS ¿STABLE¿. THIS REPORT IS BEING RAISED ON THE BASIS OF THE REPORTED INJURY OF PAIN AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586042 REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE CLIP, REMOVABLE (SKIN) FZQ CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202304135 00653405037012

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Other