BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NODRIP BASE FOAM PADDLING

    MDR report key: 3675352 · Received March 7, 2014

    Report

    Report Number
    MW5034894
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MPR (MADISON POLYMERIC ENGINEERING)
    Product Code
    FRG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MADISON POLYMERIC ENGINEERING MFG #: ND4600 (DESCRIPTION: NODRIP ROLL - EASY TEAR 3" PERFORATION // 12" X 32.5' ROLLS // 4 ROLL/CA) PRODUCT ACTUALLY HAD 5-3/4 - 6" ON CENTER PERFORATIONS INSTEAD OF 3" ON CENTER. (LOT #"S 9817390020414 AND 981703910713) PRODUCT DISTRIBUTED TO US BY (B)(4). DATES OF USE: AS NEEDED. DIAGNOSIS OR REASON FOR USE: USED IN STERILE PROCESSING PROCESSES WITH THE SPD DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138650 NODRIP BASE FOAM PADDLING NODRIP BASE FOAM PADDLING FRG MPR (MADISON POLYMERIC ENGINEERING) ND4600 9817390020414
    138651 NODRIP BASE FOAM PADDLING NODRIP BASE FOAM PADDLING FRG MPR MADISON POLYMERIC ENGINEERING. 9817039100713

    Patients

    Seq Age Sex Outcome Treatment
    1