MAUDE Adverse Event Report: PERFORMANCE HEALTH PERFORMANCE HEALTH ELECTRODES TENS-NMES-FES STIMULATING PERFORMA ELECTRODES; ELECTRODE, CUTANEOUS

Device Problem Use of Device Problem (1670)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

Patient was being seen at outpatient physical therapy post knee surgery.Electrode utilized was not their normal stock patient did not complain of pain but redness noted after treatment.Eventually developed into a 3rd degree burn.He is being treated at outpatient wound care.Per therapists "a couple other patients" had some redness but that was the extent of it.The date provided is the date it was reported as a third degree burn, not the date of the occurrence.He had had a couple treatments, i am not sure which date it occurred on.Fda safety report id # (b)(4).

• Brand Name: PERFORMANCE HEALTH ELECTRODES TENS-NMES-FES STIMULATING PERFORMA ELECTRODES
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): PERFORMANCE HEALTH; 28100 torch parkway, suite 700; warrenville IL 60555
• MDR Report Key: 12122597
• MDR Text Key: 260080901
• Report Number: MW5102304
• Device Sequence Number: 1
• Product Code: GXY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 89