BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED

    MDR report key: 2821863 · Received November 6, 2012

    Report

    Report Number
    2210968-2012-07083
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    August 18, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PROBLEM WITH PIGMENTATION. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE THREE PORT AREAS OF THE CHEST IS WHERE IS REACTION OCCURRED. THE SYMPTOMS WERE REDNESS AND RASH. AS OF (B)(6) 2012, THE REDNESS, RASH AND ITCHING WERE GONE, BUT THERE WAS PIGMENTATION. THE PATIENT IS DOING WELL.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: EAE182. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THYMIC TUMOR RESECTION ON (B)(6) 2012 AND A TOPICAL SKIN ADHESIVE WAS USED AT THE PORT AREAS. ON (B)(6) 2012 THE PATIENT DEVELOPED REDNESS AND ITCHING AT THE SITE OF APPLICATION. ON (B)(6) 2012, THE TOPICAL ADHESIVE WAS REMOVED AND THE PATIENT WAS TREATED WITH ALLEGRA AND ANTEBATE. THE PATIENT'S SYMPTOMS RESOLVED. ON (B)(6) 2012 COMPLAINED OF ITCHING AGAIN. THE DOCTOR PRESCRIBED ALLEGRA AND ANTEBATE AGAIN. UNSPECIFIED ORAL MEDICINE WAS ALSO PRESCRIBED. NOW, THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE MPN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention