BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED

    MDR report key: 3023475 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02879
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS 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 SPINAL PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT DEVELOPED AN INFECTION AND REQUIRED READMISSION TO THE HOSPITAL TO HAVE THE WOUND WASHED OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126355 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE MPN ETHICON, INC. NA EEB724

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R