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

Catalog Number DYNJ81653B

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 10/17/2023

Event Type  Injury  

Event 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".

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.

• Type of Device: 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
• MDR Text Key: 327785508
• Report Number: 1423395-2023-00071
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 10195327457099
• UDI-Public: 10195327457099
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/09/2023
• 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