BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMALGATOME SD

    MDR report key: 11872964 · Received May 24, 2021

    Report

    Report Number
    3011981870-2021-01634
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 24, 2021
    Manufacturer
    EXSURCO MEDICAL, INC.
    Product Code
    GFD
    UDI-DI
    00810006780017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MALFUNCTION DID NOT OCCUR; DEVICE WAS EVALUATED AND FOUND TO BE IN CONFORMANCE, NO PROBLEM WAS FOUND WITH THE DEVICE. HOWEVER, 50% OF THE GRAFT WAS DISCARDED. A NEW WOUND SITE WAS CREATED DUE TO THE DISCARD. PATIENT IS HEALING WELL.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT THE ASD IS LEAVING CIRCULAR MARKS ON THE EXCISION SITE. THE BLADE WAS CHANGED AND DONOR SITE WAS TAKEN WITH THE SAME RESULTS. DR. (B)(6) IS REQUESTING A LOANER WHILE WE EVALUATE THEIR UNIT. HE IS A SKILLED USER WITH THE DEVICE AND USES IT 3-4 TIMES A DAY. THIS IS THE FIRST TIME HE HAS SEEN THIS ON A PATIENT. SOME OF THE GRAFT TAKEN WAS USABLE, 50% OF THE GRAFT TAKEN WAS DISCARDED. THE EXCISION RINGS (BLADES) WERE NOT KEPT OR SENT BACK FOR REVIEW. THE EXCISION WAS FROM THE PATIENTS RIGHT ABDOMEN MIDDLE QUADRANT AND THE GRAFT WAS RIGHT POSTERIOR THIGH. SERIAL # (B)(4) OF HANDPIECE AND 4" EXCISION RINGS (BLADES) LOT: X-0000000000019. EXSURCO MEDICAL REQUESTED ADDITIONAL INFORMATION FROM FACILITY (3 ATTEMPTS). ASKED FOR STATUS ON THE PATIENT AND ON THE GRAFT USABILITY. IN ADDITION, EXSURCO SALES WAS ON SITE WEEK OF (B)(6) 2021. PLAN FOR VISIT IS TO INTRODUCE CUSTOMER TO THE TRAINING APPLICATION. EXSURCO REPRESENTATIVE WAS ABLE TO SPEAK WITH DR. (B)(6) ON (B)(6) 2021. HE APOLOGIZED FOR NOT RESPONDING TO THE EMAIL YET AS HE WAS ON VACATION ALL LAST WEEK. HE PROVIDED THE ANSWERS TO THE FOLLOWING QUESTIONS: WHY WASN'T THE GRAFT USED/DISCARDED? DESCRIPTION OF GRAFT (SHREDDED, LARGE HOLES, ETC.) THAT WAS WHY IT WAS DISCARDED. HALF OF THE GRAFT WAS SHREDDED AND DISCARDED. IS THE PICTURE THAT WAS PROVIDED THE SECTION THAT WAS DISCARDED? NO, THAT WAS WHAT WAS USED OF THE GRAFT TAKEN, PICTURE WAS SENT ONLY TO SHOW THE MARKINGS ON THE GRAFT. THE OTHER HALF WAS DISCARDED. WAS NEW GRAFT SITE CREATED DUE TO THIS? YES A NEW DONOR SITE WAS CREATED DUE TO THE DISCARD, IT HAD THE SAME MARKINGS BUT WAS USABLE. HOW IS THE PATIENT DOING? GRAFT SITE HEALING? THE PATIENT IS HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769894 AMALGATOME SD DERMATOME GFD EXSURCO MEDICAL, INC. DRIVE UNIT, AMALGATOME SD 00810006780017

    Patients

    Seq Age Sex Outcome Treatment
    1