MAUDE Adverse Event Report: METRON/ PATTERSON BRAND/ PERFORMANCE HEALTH METRON SELF ADHESIVE ELECTRODES; ELECTRODE, CUTANEOUS

Model Number 2" (50 MM) SQ-POUCH

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/27/2021

Event Type  Injury  

Event Description

Patient had physical therapy appointment on (b)(6) 2021.During appointment e-stim treatment was performed.After removal of electrodes, skin appeared fine.The next day, (b)(6) 2021 the patient reported that she had developed a single, small circular burn-like sore in the area where the electrodes were placed.Because the report from the patient was not received until the next day, the electrodes were not saved and were disposed of.Fda safety report id# (b)(4).

• Brand Name: METRON SELF ADHESIVE ELECTRODES
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): METRON/ PATTERSON BRAND/ PERFORMANCE HEALTH; 28100 torch parkway; ste 700; warrenville IL 60555
• MDR Report Key: 12751341
• MDR Text Key: 280479127
• Report Number: MW5105128
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 2" (50 MM) SQ-POUCH
• Device Lot Number: 172026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White