BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODERM EXTRA THIN CGR DRESSING

    MDR report key: 4059324 · Received August 18, 2014

    Report

    Report Number
    1049092-2014-10482
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    February 1, 2012
    Report Date
    February 9, 2012
    Manufacturer
    CONVATEC INC
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE BATCH RECORD REVIEW WAS PERFORMED. IN PROCESS SAMPLING OF INTERMEDIATE SUB-ASSEMBLIES ADN THE FINISHED PRODUCT WAS PERFORMED AND DOCUMENTED WHERE APPROPRIATE. COMPONENTS WERE APPROVED FOR USE. THE BATCH RECORD REVIEW FOUND NO OBJECTIVE EVIDENCE OF DISCREPANCIES RELATED TO THE COMPLAINT ISSUE. .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED ERYTHEMA AND BLISTER ALL AROUND THE WOUND AFTER THE DRESSING WAS APPLIED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494695 DUODERM EXTRA THIN CGR DRESSING OCCLUSIVE WOUND DRESSINGS NAD CONVATEC INC 187922 9D49798

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention