BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ELASTOMERIC PUMP

    MDR report key: 24199500 · Received January 28, 2026

    Report

    Report Number
    2026095-2026-00003
    Event Type
    Injury
    Date Received
    January 28, 2026
    Report Date
    April 30, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 27-JAN-2026 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, INC. 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.

    Description of Event or Problem · 0

    FILL VOLUME: UNKNOWN, FLOW RATE: 10 ML, PROCEDURE: TOTAL SHOULDER, DATE OF PROCEDURE: ON (B)(6) 2025, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT WAS HAVING A "NORMAL RECOVERY AND HIS HAND NUMBNESS WAS MOSTLY GONE THIS MORNING. HE STARTED NOTICING NUMBNESS IN HIS FINGERS, AND HIS ARM IS NUMB NOW AND SOME NUMBNESS IN HIS FACE. NO DROOP IN FACE. THEY ARE SUPPOSED TO TAKE OUT TOMORROW AND HE TOOK AN 'OXY' [PAIN MEDICATION] AN HOUR AGO BEFORE THIS NUMBNESS STARTED. HE IS A DOCTOR, HAD THEM CLAMP PUMP OFF. (PATIENT) IS WORRIED HE IS HAVING A STROKE. GUIDED HIM TO CONTACT HIS DOCTOR OR ANESTHESIA AT THE HOSPITAL TO REPORT HIS SYMPTOMS AND TO LEAVE THE PUMP CLAMPED UNTIL HE RECEIVES FURTHER MEDICAL GUIDANCE. EXPLAINED THE LOCAL ANESTHETIC. GUIDED THEM TO CALL URGENT SERVICE IF HIS SYMPTOMS WORSEN IF HE CAN'T GET IN TOUCH WITH HIS DOCTORS. THEY WILL CALL BACK IF NEEDED. THEY DID TALK TO NURSE AND INSTRUCTED TO GO TO ER [EMERGENCY ROOM]. AFTER CLAMPING THE PUMP OFF WIFE STATED SYMPTOMS DIDN'T GET BETTER AND GOT A LITTLE WORSE. THEY HAD SCANS AND STROKE CHECKS AND ALL LOOKED GOOD. THEY TALKED WITH ANESTHESIA AT THE HOSPITAL, AND THEY WENT AHEAD AND REMOVED THE PUMP. THE NUMBNESS IS STARTING TO GO AWAY, AND HE IS FEELING BETTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398279 UNKNOWN ELASTOMERIC PUMP ELASTOMERIC - SAF MEB AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other