BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAL INSTRUMENT CABLE

    MDR report key: 9735222 · Received February 20, 2020

    Report

    Report Number
    2020601-2020-00001
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    January 16, 2020
    Report Date
    February 20, 2020
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON DEVICE HISTORY RECORD REVIEW AND PRODUCT EVALUATION, THE FAILURE PRESENT APPEARS TO BE THE RESULT OF MIS-HANDLING AND FAILURE, ON THE USER'S BEHALF, TO PERFORM ADEQUATE INSPECTION AND MAINTENANCE PER INSTRUCTIONS FOR USE. ADDITIONALLY, PER INSTRUCTIONS FOR USE, THE INSTRUMENT CABLE SHOULD NOT BE PLACED ON THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LIPOSUCTION PROCEDURE, ON (B)(6) 2020, AN INSTRUMENT CABLE WAS PLACED ON THE PATIENT'S CHEST DURING HARVESTING OF FAT FROM THEIR THIGHS. ONCE THE HARVESTING WAS COMPLETED (AFTER FIFTEEN TO TWENTY MINUTES), THE PRACTITIONER MOBILIZED THE SECTION OF THE CABLE PLACED ON THE PATIENT'S CHEST. IT WAS THEN OBSERVED THAT THE PATIENT SUSTAINED A POSSIBLY SECOND OR THIRD DEGREE BURN TO THEIR CHEST IN THE AREA WHERE THE CABLE MADE CONTACT. IT WAS NECESSARY TO PERFORM AN EXCISION OF THE BURNED TISSUE AND SUBSEQUENTLY SUTURE THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198765 PAL INSTRUMENT CABLE PAL INSTRUMENT CABLE HWE MICROAIRE SURGICAL INSTRUMENTS, LLC 5006-PAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other