BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN, ELASTOMERIC LFR

    MDR report key: 15924432 · Received December 6, 2022

    Report

    Report Number
    2026095-2022-00132
    Event Type
    Injury
    Date Received
    December 6, 2022
    Report Date
    December 6, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 05 DEC 2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC.. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    FILL VOLUME: UNKNOWN ML. FLOW RATE: UNKNOWN. PROCEDURE: RIGHT ACL RECONSTRUCTION. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2022. INFUSION STOP TIME: (B)(6) 2022. THE PATIENT REPORTED, THEY NOTED RINGING IN THEIR EARS, DROWSINESS, AND BLADDER CHANGES; THEY REMOVED THE POST PROCEDURE (ACL) ON-Q PUMP AT HOME ON (B)(6) 2022; THE PUMP STILL LOOKED TO HAVE ABOUT HALF OF THE MEDICATION STILL IN THE BALL WHEN IT WAS REMOVED. ALL THE SYMPTOMS REPORTEDLY RESOLVED EXCEPT THE ¿BUZZING¿ IN THEIR EARS. DURING FOLLOW-UP (F/U) WITH THEIR SURGEON, ON (B)(6) 2022, THE PATIENT NOTED THE ¿BUZZING¿ IN THEIR EARS WAS STILL AN ISSUE AND THEY WERE ADVISED TO F/U WITH THEIR PHYSICIAN. THE PATIENT REPORTEDLY WENT TO PHYSICAL THERAPY TO TREAT THE DIZZINESS FOR THE ¿RINGING¿ IN THEIR EARS WITHOUT SUCCESS, THEY ALSO TRIED TAKING THE WAX OUT OF THEIR EARS. THE PHYSICIAN RECOMMENDED THEY F/U WITH AN EAR NOSE AND THROAT (ENT) SPECIALIST. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769443 UNKNOWN, ELASTOMERIC LFR ELASTOMERIC LFR MEB AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other NAROPIN