BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KELLER FUNNEL2 (1PK)

    MDR report key: 18445657 · Received January 4, 2024

    Report

    Report Number
    3011299751-2024-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    December 12, 2023
    Report Date
    June 14, 2024
    Manufacturer
    ALLERGAN (KELLER)
    Product Code
    KDD
    UDI-DI
    10888628043732
    PMA / PMN Number
    510(K)EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: "BREAST IMPLANT WOULD NOT PASS THROUGH FUNNEL."

    Additional Manufacturer Narrative · 0

    SAMPLE INVESTIGATION: NO DAMAGE WAS OBSERVED. A COATING EVALUATION WAS PERFORMED. FOR THE INTERIOR SURFACE, PORTIONS WERE OBSERVED TO BE LUBRICIOUS AND OTHER PORTIONS WERE OBSERVED TO NOT BE LUBRICIOUS. SINCE CONSISTENT LUBRICITY WAS NOT OBSERVED, THE EXPECTED RESULT WAS NOT MET. THE EXTERIOR SURFACE OF THE FUNNEL WAS NOT OBSERVED TO BE LUBRICIOUS, WHICH MEETS THE EXPECTED RESULT. DESPITE OBSERVATIONS MADE DURING THE COATING EVALUATION, A FUNCTIONAL/ LUBRICITY EVALUATION WAS PERFORMED TO IDENTIFY IF THERE IS SUFFICIENT LUBRICATION TO PASS AN IMPLANT THROUGH THE FUNNEL. DURING THE FUNCTIONAL/ LUBRICITY EVALUATION, THE BREAST IMPLANT COULD NOT BE PASSED THROUGH THE FUNNEL. SINCE THE BREAST IMPLANT WAS UNABLE TO PASS THROUGH THE FUNNEL, NO FURTHER ATTEMPT TO PASS THE IMPLANT THROUGH WAS PERFORMED. THE PROBABLE CAUSE FOR THE INTERIOR SURFACE OF THE FUNNEL TO NOT BE SUFFICIENTLY LUBRICIOUS IS UNKNOWN; HOWEVER, A MANUFACTURING ERROR IS SUSPECTED. ABBVIE DEVICE QUALITY ASSURANCE (DQA) WAS NOTIFIED OF THE CONDITION OF THE SAMPLE. PER DISCUSSION AND REVIEW WITH DQA, THE CURRENT COMPLAINT SAMPLE IS ASSOCIATED WITH KELLER FUNNEL BATCH 24B42C. A RECALL FOR KELLER FUNNEL BATCH 24B42C WAS INITIATED BY FORMACOAT. NO FURTHER EVALUATION IS REQUIRED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "BREAST IMPLANT WOULD NOT PASS THROUGH FUNNEL." PATIENT CONTACT DID OCCUR.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "BREAST IMPLANT WOULD NOT PASS THROUGH FUNNEL." PATIENT CONTACT DID OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558862 KELLER FUNNEL2 (1PK) KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD ALLERGAN (KELLER) NI 10888628043732

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female