BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIHESIVE

    MDR report key: 23153828 · Received September 26, 2025

    Report

    Report Number
    9618003-2025-02701
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Report Date
    September 1, 2025
    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

    E1: COMPLAINANT STREET ADDRESS: (B)(6) COMPLAINANT COUNTRY: SPAIN COMPLAINANT PHONE: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE FOR EVALUATION IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). NO SAMPLES WERE AVAILABLE FOR THIS COMPLAINT, AND THEREFORE IT WAS NOT POSSIBLE TO CONFIRM THE COMPLAINT. BATCH RECORD REVISION RESULTS: LOT 4J03675 WAS MANUFACTURED ON 26/SEP/2024, IN DOYEN B LINE, WITH A TOTAL OF (B)(6) MARKET UNITS (MKUS). THE COMPLAINTS INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 22/SEP/2025, 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 IDENTIFICATION (ID) 1103418 AND MANUFACTURING ORDER (B)(4). REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. THE REPORTED MALFUNCTION COULD BE GENERATED DURING THE MANUFACTURING PROCESS OF THE FINAL LINE, THEREFORE NO FURTHER BATCH RECORD REVIEW OF THE SUBASSEMBLY LOTS WAS REQUIRED. HISTORICAL COMPLAINTS REVIEW: ON 22/SEP/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4J03675 LOT FOR THE MALFUNCTION ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE)¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 22/SEP/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE)¿ FOR THE SPECIFIC DEFECT FOR THE LOT NUMBER 4J03675 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. CURRENT QUALITY CONTROLS: BASED ON THE PROCESS INSTRUCTION (PI), THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: TEST METHODS (TM) ¿ROLLING BALL TACK TEST¿: FREQUENCY: 2 SAMPLES SAMPLE QUANTITY: 2 SAMPLES ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 1 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4), WHICH WAS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT WHICH SHOULD BE 0.65% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT WAS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 0.65. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT WAS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: AS NO PHOTOGRAPHS OR SAMPLES WERE AVAILABLE FOR THIS COMPLAINT ISSUE, IT WAS NOT POSSIBLE TO RAISE AN INVESTIGATION FOR THE ISSUE REPORTED. A BATCH RECORD REVIEW WAS COMPLETED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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

    THE PHARMACIST STATED THAT THE PATIENT HAD A SKIN REACTION AS THE DRESSING HAD SUCH ADHERENCE THAT WAS IMPOSSIBLE TO REMOVE. FURTHERMORE, PHARMACIST MENTIONED THAT THE PATIENT HAD TO VISIT THE HEALTH CARE CENTER TO RECEIVE THE SKIN TREATMENT. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111794 VARIHESIVE NOT APPLICABLE NAD CONVATEC DOMINICAN REPUBLIC INC 187638 4J03675

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown