MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CHEST/BREAST PACK

Catalog Number	DYNJ81653B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2023 "while performing a breast augmentation the handpiece was leaving small burns on the patient's skin where the tip was not touching".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 "while performing a breast augmentation the handpiece was leaving small burns on the patient's skin where the tip was not touching".Per the facility they were not aware where the burns came from "until the bovie was activated again and we saw a spark come from the junction where the tip was connected to the handpiece".Per the facility the wound on the patient's left breast was dressed with antibiotic ointment.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: CHEST/BREAST PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18106273
• Report Number: 1423395-2023-00071
• Device Sequence Number: 6003826
• Product Code: FTN
• UDI-Device Identifier: 10195327457099
• UDI-Public: 10195327457099
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ81653B
• Device Lot Number: 23GBR673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown