BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRIER SURGICAL GOOD - CAP TUCK BLUE

    MDR report key: 4281473 · Received November 20, 2014

    Report

    Report Number
    3004763499-2014-00020
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 16, 2014
    Report Date
    November 17, 2014
    Manufacturer
    MOLNLYCKE HEALTHCARE
    Product Code
    FYF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT WAS ANESTHETIZED. LINT ENTERED THE SURGICAL SITE BUT WAS REMOVED SUCCESSFULLY. WOUND WAS CLOSED UP AND SURGERY WAS POSTPONED. HE WAS PLACED ON ANTIBIOTICS. IT IS UNK WHETHER PT EXPERIENCED ANY POSTOPERATIVE COMPLICATIONS OR WHETHER HE PRESENTED AT FOLLOW UP WITH ANY PROBLEMS THAT COULD BE ASSOCIATED WITH RETAINED LINING MATERIAL.

    Description of Event or Problem · 1

    (B)(4). THE BARRIER SURGICAL HOOD, 620105, WAS SHEDDING IN (B)(6) AND FALLING FROM THE TOP OF THE HOOD FROM THE HEALTHCARE WORKER INTO THE STERILE SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753683 BARRIER SURGICAL GOOD - CAP TUCK BLUE FYF MOLNLYCKE HEALTHCARE 620105 13056504

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other