BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1150548 · Received September 4, 2008

    Report

    Report Number
    2210968-2008-00774
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 31, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    CUSTOMER REPORTED THAT A PATIENT DEVELOPED A RASH AT THE SITE OF A HICKMAN CATHETER. THE PATIENT WAS PRESCRIBED ELOCON CREME AND REFERRED TO A DERMATOLOGIST. THE EVENT RESOLVED FOLLOWING MILD CLEANSING TO REMOVE SKIN PREP AND ADHESIVE BANDAGE RESIDUE. THE DERMATOLOGIST OPINES THAT THE EVENT IS RELATED TO THE SKIN PREP AND ADHESIVE RESIDUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TRACLEER| SKIN PREP| ADHESIVE BANDAGES