BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM SYNERGY 2PC DURAHESIVE MOLDABLE WAFER

    MDR report key: 3733577 · Received March 31, 2014

    Report

    Report Number
    1049092-2014-00081
    Event Type
    Injury
    Date Received
    March 31, 2014
    Date of Event
    March 2, 2014
    Report Date
    March 6, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. HE REPORTS HE HAS A SOCCER BALL SIZED PERISTOMAL HERNIA AND AN UMBILICAL HERNIA. HE REPORTS THAT HE COVERS THE WOUND WITH (B)(4) EXTRA THIN WITH EACH WAFER CHANGE. THE END USER INFORMED THAT HE USES (B)(4) SOAP TO CLEANSE HIS PERISTOMAL SKIN AND USES (B)(4) PROTECTIVE BARRIER WIPES TO HIS PERISTOMAL SKIN. HE INFORMED THAT HE CHANGES HIS WAFER EVERY 1-2 DAYS. HE REPORTS THAT HE HAS USED (B)(4) IN THE PAST. THE END USER WAS ADVISED TO CONTACT HIS HEALTH CARE PROFESSIONAL AND RECOMMENDED TO APPLYING (B)(4) TO THE WOUND FOLLOWED BY (B)(4) EXTRA THIN. END USER WAS INSTRUCTED TO FOLLOW-UP IF THE AREA WORSENS OR NO IMPROVEMENT OCCURS. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH 3J02252 WAS MADE ACCORDING TO SPECIFICATION. AFTER DETAILED BATCH REVIEW, AND A NON CONFORMANCE REPORT (NCR) FOR (MISSING, DOUBLE, UN-WELDED, OFF CENTERED AND ROTATIONAL LANDING ZONES) WAS FOUND. IT HAS NO IMPACT ON THIS COMPLAINT. PHOTOS WERE ATTACHED TO BATCH RECORD; HOWEVER THIS IS A KNOWN COMPLAINT ISSUE WHICH HAS BEEN INVESTIGATED. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. BASED ON THE INVESTIGATION THIS NONCONFORMITY WAS POSSIBLY CAUSED BY MULTIPLE ISSUES AND THE LINE TECHNICIAN FAILURE TO CULL OUT THE DEFECTIVE PRODUCT DURING THE INSPECTION PROCESS. ADDITIONAL TRAINING INITIATIVES WERE IMPLEMENTED FOR THE OPERATORS. THIS COMPLAINT IS NOT ASSOCIATED WITH A PRODUCT MALFUNCTION. THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS AS A RESULT OF SKIN COMPLICATIONS WHICH ARE CAUSED BY A VARIETY OF EXTERNAL FACTORS NOT RELATED TO THE DESIGN, MATERIALS, AND/OR PROCESSES OF THE PRODUCT. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    END USER REPORTS HE HAS A SMALL AMOUNT OF BLEEDING AT 5 O'CLOCK POSITION. HE IS UNSURE IF IT WAS THE PERISTOMAL SKIN OR THE STOMA BECAUSE, IT IS IN A RECESSED AREA. HE REPORTS THE BLEEDING OCCURRED WHEN HE WAS CHANGING HIS WAFER YESTERDAY BUT, THE BLEEDING HAS SINCE STOPPED. HE ALSO REPORTS HE HAS AN OPEN AREA FROM 8-10 O'CLOCK, WHICH MEASURES APPROX 32MMX10MM WITH DEPTH. THE END USER REPORTS HE HAS BEEN USING THE PRODUCT SINCE APPROX (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190029 ESTEEM SYNERGY 2PC DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 409270 3J02252

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention