BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM SYNERGY 2 PC-2PC STOMAHESIVE (SH) MOLDABLE WAFER

    MDR report key: 4202353 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-10993
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    October 9, 2012
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE BATCH RECORD FOR LOT WAS PERFORMED. THE REVIEW FOUND THAT LABEL 1255534A1 WAS REQUIRED FOR THE PACKAGING LOT REPORTED (0D00327). INVESTIGATION OF THE LABEL AUTHORIZATION ON FILE IN WAS CONSISTENT WITH THE LABEL AS REPRESENTED WITHOUT THE BARCODE. A CHECK OF THE BUSINESS SYSTEM INDICATED THAT THE A1 VERSION (W/O BARCODE) WAS AN APPROVED LABEL AND WAS LISTED ON THE BILL OF MATERIAL FOR THIS PRODUCT FROM (B)(4) 2010. FURTHER INVESTIGATION INDICATES THAT THE A1 VERSION OF THE LABEL WAS MODIFIED UNDER (B)(4), CREATING THE A2 VERSION OF THIS LABEL. THE A2 VERSION OF THIS LABEL HAS ADDED THE PZN BARCODE TO THE BLANK FIELD UNDER THE REF NUMBER. THE A2 VERSION WAS MADE EFFECTIVE ON THE BILL OF MATERIAL FOR THIS PRODUCT ON (B)(6) 2010 AND IS CURRENTLY THE LABEL REQUIREMENT FOR THIS ICC CODE. CONCLUSION: LOT 0D00327 WAS LABELED ACCORDING TO THE LABELING REQUIREMENTS IN PLACE AT THE TIME THE PRODUCT WAS PACKAGED. THE LABEL A1 VERSION USED AT THAT TIME WAS APPROVED FOR USE AND DID NOT REQUIRE A BARCODE. SUBSEQUENT REVISION OF THE LABEL TO THE A2 VERSION MADE EFFECTIVE ON 08/17/2010 ADDED THE PZN BARCODE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT A PRODUCT WAS MISSING A BAR CODE LABEL. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT INVOLVEMENT OR OUTCOME IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575295 ESTEEM SYNERGY 2 PC-2PC STOMAHESIVE (SH) MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 411658 0D00327

    Patients

    Seq Age Sex Outcome Treatment
    1