MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MINOR

Catalog Number DYNJ901310D

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/31/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, while using the cautery device on (b)(6) 2023 "two holes burned through the shaft of the cautery tip causing three small (0.5 cm) superficial burn marks on the patient's nipple and areola".The customer reported due to the angle the surgeon was holding the cautery pencil, the insulated shaft was in contact with the patient's skin when burning through the shaft occurred.The customer reported after the reported incident occurred a new cautery was obtained, the procedure was able to be completed, and the surgeon applied "bacitracin" to the burn areas prior to dressing the area.The customer reported the patient stated she "is doing well and is having no issues".Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, while using the cautery device on 07/31/2023 "two holes burned through the shaft of the cautery tip causing three small (0.5 cm) superficial burn marks on the patient's nipple and areola".

• Type of Device: MINOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17618467
• MDR Text Key: 321916692
• Report Number: 1423395-2023-00040
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10889942565238
• UDI-Public: 10889942565238
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ901310D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other