BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INFUSION PUMP

    MDR report key: 2494656 · Received March 16, 2012

    Report

    Report Number
    3007566237-2012-00562
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: TURRENTINE, JAKE E., TRAVIS W. BLALOCK, AND LORETTA S. DAVIS. "UNUSUALLY SEVERE CASE OF DERMATOSIS NEGLECTA." SKINMED 10.1 (2012): 46-47. PRINT SUMMARY: THE AUTHORS PRESENT AN UNUSUALLY SEVERE CASE OF DERMATOSIS NEGLECTA THAT WAS TREATED WITH A REGIMENT OF PROPER HYGIENE AND APPLICATION OF 5% SALICYLIC ACID IN OLIVE OIL TO THE AFFECTED AREA. AT 6-WEEK FOLLOW-UP, THE UNDERLYING SCALP SHOWED AREAS OF FIBROSIS AND POSSIBLE SCARRING WITH A FEW EMERGING TUFTS OF HAIR. REPORTED EVENT: AN (B)(6) WOMAN WITH CEREBRAL PALSY WAS ADMITTED FOR EVALUATION OF AN INTRATHECAL BACLOFEN PUMP SITE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization