BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5569847 · Received April 12, 2016

    Report

    Report Number
    8043817-2016-00029
    Event Type
    Malfunction
    Date Received
    April 12, 2016
    Report Date
    March 16, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K021288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR WAS REVIEWED AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 7/10/2015. NO DEFECT WAS REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    DHR WAS REVIEWED AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 7/10/2015. NO DEFECT WAS REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1 LOT 1048190 WAS REPORTED IN THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO MICROTEK NONSTERILE LOTS D152781 AND D152751. THE DHR WAS REVIEWED FOR LOT D152781 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 10/5/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152751 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 10/2/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DHR REVIEW, THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AN END USER FOUND HOLD IN DRAPE. NOTICED AT THE END OF A CASE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    AN END USER FOUND HOLE IN DRAPE. NOTICED AT THE END OF A CASE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228011 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-300N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1