BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0750 - DUODERM

    MDR report key: 11874823 · Received May 25, 2021

    Report

    Report Number
    9618003-2021-01017
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Report Date
    May 10, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). BATCH RECORD REVIEW: LOT 9E00237 WAS MANUFACTURED ON 05/02/2019 IN THE DOYEN B WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR ID 5173 PERFORMED A BATCH RECORD REVIEW ON 08/02/2021 TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, UNDER ICC CODE 187955 SAP MATERIAL ID 1000915 AND MANUFACTURING ORDER 1468038. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: PHOTO RELATED TO THE REPORTED PROBLEM IS AVAILABLE FOR EVALUATION. INVESTIGATION SUMMARY: BASED IN THE ANALYSIS PHASE CONCLUSIONS. MATERIAL, MANPOWER, MACHINERY/EQUIPMENT/SOFTWARE AND MEASUREMENT SECTIONS WERE REVIEWED, AND IT IS CONSIDERED NONE OF THEM INTERFERED ON THE INCIDENCE OF THE ROOT CAUSE, ALSO, THESE SECTIONS AND POSSIBLE OPPORTUNITY. METHOD OPPORTUNITY: FOR THE ELC¿S AN OPPORTUNITY WAS IDENTIFIED ON THE PROCESS INSTRUCTION FOR THE HANDLING OF THE DRESSINGS ONCE THEY HAVE BEEN CUT, IT DOES NOT SPECIFY THE METHOD OF PLACEMENT, DESIGN OF THE TRAYS (HOW MANY DRESSINGS PER TRAY, HOW THEY SHOULD BE ORGANIZED). FOR ACTIONS RELATED REFER TO CAPA PLAN (B)(4). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    COMPLAINANT STATE/PROVINCE: (B)(6). PATIENT COUNTRY: (B)(6). (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BLANK INK AT THE EDGE OF THE DRESSING. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777419 L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 9E00237

    Patients

    Seq Age Sex Outcome Treatment
    1