BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5344009 · Received January 5, 2016

    Report

    Report Number
    8043817-2016-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    November 3, 2015
    Report Date
    November 5, 2015
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1: LOT 1036823 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE FOLLOWING NON STERILE LOTS FROM MICROTEK: D152251A THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT D152251 AND IT WAS SEEN THAT THERE WERE NO DEFECTS REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTIONS. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO SAMPLE NOT BEING REVIEWED THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS OF PIN HOLES IN A DRAPE WARMING 44X44 BNS P/N 5309009. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS OF PIN HOLES IN A DRAPE WARMING DRAPE 44/44 BNS, P/N 5309009. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5219 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-100N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1