BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5463405 · Received February 26, 2016

    Report

    Report Number
    8043817-2016-00021
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Report Date
    December 31, 2015
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS OR REVIEW THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. LOT 1042717 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D151351, D15611, D152541, D152641, D151611, D152581 AND D151671. THE DHR WAS REVIEWED FOR LOT D152641. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/21/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152541. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/11/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151611. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/10/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152221. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/11/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152161. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/05/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152581. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/18/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151671. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/16/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151351. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/18/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. BASED ON THE DEVICE HISTORY RECORD 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

    END USER INFORMED OF A LEAKING DRAPE WARMER 44 X 66, FOUND DURING SET UP. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    END USER REPORTED A LEAKING DRAPE WARMER 44 X 66 FOUND DURING SET UP. THERE WERE NO PATIENT INJURY OR TREATMENTS REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119896 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-320N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1