MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CAUTERY DEVICE IN BREAST AUG PACK

Catalog Number	DYNJ35686B
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a plastics procedure, the cautery device sparked and the patient experienced a 1st degree burn to an unidentified location.No medical intervention or follow-up care was reported to the manufacturer.No impact to the procedure was reported to the manufacturer.A sample was returned to manufacturer for evaluation.Sample investigation is ongoing at this time.Due to the reported spark and 1st degree burn, this medwatch is being filed.If and/or when additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a plastics procedure, the cautery device sparked and the patient experienced a 1st degree burn.
Additional Manufacturer Narrative
The manufacturer completed the investigation of the returned sample.According to the reporting facility, it was believed that blood was entering the cautery device and that this caused the reported spark.Inspection of the cautery device identified blood on the indent of the device.When the cautery device casing was opened, no blood ingress was identified within the body.The blood was present only to the surface of the casing and it is highly unlikely that the reported spark originated from the cautery device.A root cause for the reported incident could not be determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: CAUTERY DEVICE IN BREAST AUG PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8758437
• Report Number: 1423395-2019-00023
• Device Sequence Number: 2565864
• Product Code: FTN
• UDI-Device Identifier: 10889942488315
• UDI-Public: 10889942488315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ35686B
• Device Lot Number: 18FBA604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other