BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM

    MDR report key: 1964064 · Received January 11, 2011

    Report

    Report Number
    2210968-2011-00034
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    December 13, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION SURGICAL PROCEDURE ON (B)(6) 200 AND TOPICAL SKIN ADHESIVE WAS USED. WHEN THE PATIENT RETURNED FOR A FOLLOW-UP DOCTOR VISIT ON (B)(6) 2010, SHE HAD AN ALLERGIC REACTION TO THE TOPICAL SKIN ADHESIVE WITH SEVERE REDNESS, IRRITATION AND EDEMA. THE TOPICAL SKIN ADHESIVE WAS REMOVED AND THE PATIENT WAS PRESCRIBED DURICEF AND A STEROID CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT MPN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK