BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EST+ DRNPRECUTINVISICLR38MM(1X10) NAI

    MDR report key: 8115744 · Received November 29, 2018

    Report

    Report Number
    9618003-2018-03652
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXB
    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 8C03437 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 IT IS NOT REQUIRED TO OPEN A NONCONFORMANCE REPORT (NCR) FOR TYPE 2 COMPLAINTS WHICH WERE NOT CONFIRMED. LOT 8C03437 WAS MANUFACTURED ON 04/13/2018, APS MANUAL 3 LINE, WITH A TOTAL OF (B)(4) UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 09/28/2020, EST+ DRNPRECUTINVISICLR38MM(1X10) NAI 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 1709643 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

    (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 THE STARTER HOLE WAS OFF CENTER IN THREE WAFERS. THE PRODUCT WAS NOT USED AND NO PHOTO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957762 EST+ DRNPRECUTINVISICLR38MM(1X10) NAI NOT APPLICABLE EXB CONVATEC DOMINICAN REPUBLIC INC 421024 8C03437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown