MAUDE Adverse Event Report: HALYARD HEALTH / AVANOS MEDICAL, INC. HALYARD DISPERSIVE ELECTRODE; ELECTRODE, ELECTROSURGICAL

Model Number P60-FMA-GF-BAY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)

Event Date 08/06/2019

Event Type  Injury  

Event Description

Pt was admitted for radio-ablation procedure.Post-procedure the pt felt a burning pain on the back of her knee.A small blister was noted in the area.The injury was most likely due to the grounding pad used during the procedure.Post-discharge the pt went to (b)(6) and it was determined to be a 2nd degree burn and treated.

• Brand Name: HALYARD DISPERSIVE ELECTRODE
• Type of Device: ELECTRODE, ELECTROSURGICAL
• Manufacturer (Section D): HALYARD HEALTH / AVANOS MEDICAL, INC.; alpharetta GA
• MDR Report Key: 8970780
• MDR Text Key: 158638105
• Report Number: MW5089607
• Device Sequence Number: 0
• Product Code: JOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2020
• Device Model Number: P60-FMA-GF-BAY
• Device Catalogue Number: P60-FMA-GF-BAY
• Device Lot Number: 201809255
• 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): Required Intervention
• Patient Age: 66 YR