BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX

    MDR report key: 14338640 · Received May 9, 2022

    Report

    Report Number
    2027111-2022-00593
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    January 11, 2022
    Report Date
    August 3, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915132941
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE PRESENCE OF HAIR INSIDE THE STERILE UNOPENED POUCH. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, THE HAIR LIKELY ORIGINATED FROM AN OPERATOR DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT [FACILITY] INSPECTION PO# (B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. THERE ARE ITEMS REQUIRE CER IN THIS REPORT. C8323 LOT #1432996 - PARTICULATE: HAIR(1 EA.) PATIENT STATUS: (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: (INCOMING INSPECTION).

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT [FACILITY] INSPECTION PO#(B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. THERE ARE ITEMS REQUIRE CER IN THIS REPORT. C8323 LOT #1432996 PARTICULATE: HAIR(1 EA.). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243360 C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL KGW APPLIED MEDICAL RESOURCES C8323 1432996 00607915132941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown