BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT SHORT STEM FLEX 2-1/4

    MDR report key: 11358132 · Received February 22, 2021

    Report

    Report Number
    1216677-2021-00019
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    December 2, 2020
    Report Date
    November 2, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHW
    PMA / PMN Number
    K904774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INITIATED MANUFACTURER'S INVESTIGATION NO SAMPLE RETURNED REVIEW DHR INSPECT STOCK PRODUCT *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI IN MAY 2020 UNDER WORK ORDER 276529. MANUFACTURING RECORD REVIEW (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. HOWEVER, THERE WERE FINISHED GOODS PRODUCT OF THE REPORTED LOT NUMBER AVAILABLE FOR EVALUATION. VISUAL EVALUATION VISUAL EXAMINATION OF FINISHED GOODS INVENTORY FOR THIS LOT NUMBER FOUND THE PARTS INSIDE THE PACKAGE WERE AS DESCRIBED IN THE REPORTED COMPLAINT, LONG STEM GELLHORN WERE INSIDE INSTEAD OF SHORT STEM GELLHORN. FUNCTIONAL EVALUATION COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE THE WRONG MOLDS WERE USED TO MOLD THE PRODUCT. CAPA 746 AND NCMR 13431 WERE OPENED. *CORRECTION AND/OR CORRECTIVE ACTION CAPA 746 AND NCMR 13431 COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. TRAIN PERSONNEL *WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    REPORT STATED "THE LABELS OF THE ORDERED PESSARIES (GELLHORN SHORTS 2 1/4") WERE CORRECT BUT THE PESSARIES INSIDE OF EACH BOX CAME GELLHORN REGULAR 2 1/4" 1216677-2021-00019-1 KIT SHORT STEM FLEX 2-1-4 MXKPGSS2-1-4 E-COMPLAINT-2021-02-0000012.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    (B)(4). REPORT STATED "THE LABELS OF THE ORDERED PESSARIES (GELLHORN SHORTS 2 1/4") WERE CORRECT BUT THE PESSARIES INSIDE OF EACH BOX CAME GELLHORN REGULAR 2 1/4". KIT SHORT STEM FLEX 2-1 4 MXKPGSS2-1 4 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254207 KIT SHORT STEM FLEX 2-1/4 KIT SHORT STEM FLEX 2-1/4 HHW COOPERSURGICAL, INC. MXKPGSS2-1/4 276529

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other