BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GROUNDING PAD

    MDR report key: 8423976 · Received March 15, 2019

    Report

    Report Number
    3011270181-2019-00009
    Event Type
    Injury
    Date Received
    March 15, 2019
    Date of Event
    February 21, 2019
    Report Date
    February 21, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSO
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HE 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 14-MAR-2019 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIANS WERE PERFORMING A LEFT GENICULAR PROCEDURE ON A PATIENT WHO HAD A TOTAL KNEE REPLACEMENT, THE PATIENT ALSO HAD HARDWARE IN HER UPPER LEG. THE CLINICIANS HAD THE GROUNDING PAD POSITIONED VERTICAL ON THE PATIENT'S CALF. THE PATIENT HAD TWO "DISCREET BURNS-1CM EACH" AT TWO CORNERS OF PAD SITE. THERE WAS NO TREATMENT GIVEN. THE PATIENT WENT TO AN URGENT CARE LATER BUT IT WAS UNKNOWN IF ANY TREATMENT WAS GIVEN. IT WAS RECOMMENDED THE PATIENT SEE A DERMATOLOGIST. THE NURSE DID NOT KNOW IF THE PATIENT HAD LOTION ON HER LEG. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219237 UNKNOWN GROUNDING PAD PAIN MANAGEMENT GENERATORS & ACCESSORIES BSO AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention