BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8148031 · Received December 10, 2018

    Report

    Report Number
    9618003-2018-04012
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D4: UNIQUE IDENTIFIER (UDI) H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY NO SAMPLES OR PHOTOS WERE RECEIVED FOR ANALYSIS AND INVESTIGATION; FOR THAT REASON, THE MALFUNCTION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. IN ADDITION, A COMPLAINT SEARCH FOR LOT 8D05096 AND MALFUNCTION SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY) WAS CARRIED OUT AND AS A RESULT, NO ADDITIONAL COMPLAINT WAS FOUND; THEREFORE, NO TREND IS OBSERVED. AS PER COMPLAINT MANUFACTURING INVESTIGATION PROCEDURE WORK INSTRUCTION (WI), IT IS NOT REQUIRED TO OPEN A NONCONFORMANCE REPORT (NCR) FOR THESE COMPLAINTS WHICH WERE NOT CONFIRMED. LOT 8D05096 WAS MANUFACTURED ON 05/08/2018, CONVEX 2 PIECE (PC) LINE, WITH A TOTAL OF (B)(4)UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 09/28/2020, DESCRIPTION SURFIT NATURA S4S WFR CVX25/45MM1X5NL/GB TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT. SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1052419 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS 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

    PATIENT COUNTRY: (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.

    Description of Event or Problem · 1

    IT WAS REPORTED 20 SKIN BARRIERS HAVE THE HOLE OUT OF THE CENTER. NO PHOTO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987614 NATURA NOT APPLICABLE EXE CONVATEC DOMINICAN REPUBLIC INC 402204 8D05096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown