MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BASIN SET

Catalog Number	DYNJ50906B
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during use of the insulated tip cautery pencil in a breast augmentation procedure, the patient sustained skin burn within the incision site.General anesthesia was used; however there was no effect on the patient's stability as a result of the incident.The sample has been returned and evaluated including an insulated tip that was not a part of the pre-packaged basin set pack.During sample evaluation, the cautery pencil functioned without an issue on dispersion of heat or current from the cautery blade beyond point of contact.A root cause cannot be determined at this time.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient sustained skin burn within the incision site during use of insulated tip cautery pencil.

• Common Device Name: BASIN SET
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7252134
• Report Number: 1423395-2018-00001
• Device Sequence Number: 957626
• Product Code: LRO
• UDI-Device Identifier: 10889942464883
• UDI-Public: 10889942464883
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: Physician
• Device Catalogue Number: DYNJ50906B
• Device Lot Number: 17KDO726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/08/2018
• 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
• Patient Age: 30 YR
• Patient Weight: 47