BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEXIS O WOUND PROTECTOR-RETRACTOR

    MDR report key: 20080817 · Received August 27, 2024

    Report

    Report Number
    2027111-2024-00803
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    March 18, 2024
    Report Date
    December 5, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915117252
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION, BUT LOT NUMBER IS PROVIDED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCE'S THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE DESCRIPTION OF THE EVENT IT IS POSSIBLE THAT THE REPORTED EVENT UNIT WAS MANUFACTURED WITH DAMAGES OR NON-CONFORMANCE'S ON THE DEVICE AND FALSELY PASSED MANUAL INSPECTION. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: COLECTOMY. DESCRIPTION OF EVENT: [HOSPITAL] PRODUCT: C8401. DURING THE CASE, THE DOCTOR TRIED ROLLING THE ALEXIS ONLY ONCE ROLLING THEN THE RETRACTION RING(WHITE) WAS BROKEN. NO PRODUCT RETURNING. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: COLECTOMY. DESCRIPTION OF EVENT: [HOSPITAL]. PRODUCT: C8401. DURING THE CASE, THE DOCTOR TRIED ROLLING THE ALEXIS ONLY ONCE ROLLING THEN THE RETRACTION RING(WHITE) WAS BROKEN. NO PRODUCT RETURNING. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180421 ALEXIS O WOUND PROTECTOR-RETRACTOR RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL KGW APPLIED MEDICAL RESOURCES C8401 1456661 00607915117252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown