MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK MASTECTOMY COMBO CHRG

Catalog Number	DYNJ60232A
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "a bovie tip broke down during a case and caused a superficial skin burn on the patient's breast." email received by assistant clinical nurse manager, operating room, evanston hospital with additional information in regards to this incident.Reporter states, on (b)(6) 2020 a patient experienced a "superficial skin burn to the left breast" during a left breast nipple sparing mastectomy w/sentinel node biopsy with immediate reconstruction and tissue expander surgery." reporter states, patient was under general anesthesia at the time.No serious injury, medical intervention or follow-up was required.Reporter states, patient is reported as having "no, reported issues." the sample has not been return for evaluation.Therefore, a root cause has not been determined at this time.No further information is available.Due to the reported incident, medical intervention and 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.
Event or Problem Description
It was reported, "a bovie tip broke down during a case and caused a superficial skin burn on the patient's breast.".

• Common Device Name: PACK MASTECTOMY COMBO CHRG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10907366
• Report Number: 1423395-2020-00035
• Device Sequence Number: 910358
• Product Code: FTN
• UDI-Device Identifier: 10193489246681
• UDI-Public: 10193489246681
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: DYNJ60232A
• Device Lot Number: 20EMB142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/26/2020
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 56