BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMACEA GZE SPG 4X4 12PLY STR

    MDR report key: 15319254 · Received August 30, 2022

    Report

    Report Number
    1282497-2022-10717
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Report Date
    September 28, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    NAB
    UDI-DI
    10884521066038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED SHOWING NO EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. NO SAMPLE WAS AVAILABLE FOR INVESTIGATION; HOWEVER, A PHOTO WAS PROVIDED. THERE IS NO ABNORMAL PHENOMENON FOUND ON THE SAMPLE PHOTO. THE SUPPLIER CHECKED THEIR RETAINED SAMPLE AND FOUND NO FRAYING. THE SUPPLIER PERFORMS A QUALITY INSPECTION DURING THE PROCESS. FROM THE INVESTIGATION, THERE IS NO ABNORMALITIES FOUND IN PRODUCTION PROCESS, RETAINED SAMPLE, OR THE DHR. THE SUPPLIER IS UNABLE TO DETERMINE THE ROOT CAUSE. THE RELEVANT SECTORS OF MANUFACTURING WERE INFORMED OF THE COMPLAINT INFORMATION FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME. THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE GAUZE IS FRAYING WHEN USED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE GAUZE WAS USED IN THE OPERATING ROOM AND DELIVERY ROOM. WHEN THE DOCTORS USE IT AND REMOVE IT FROM WHERE THEY PLACE IT IN THE PATIENT, THE THREAD COMES OUT AND THE GAUZE FRAYS LITTLE BY LITTLE; THE THREAD DOESN¿T COME OUT COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274121 DERMACEA GZE SPG 4X4 12PLY STR GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE NAB CARDINAL HEALTH 441000 210930-128-SH 10884521066038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown