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

Catalog Number DYNJ60232A

Device Problem Break (1069)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/28/2020

Event Type  malfunction  

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 Description

It was reported, "a bovie tip broke down during a case and caused a superficial skin burn on the patient's breast.".

• Type of Device: PACK MASTECTOMY COMBO CHRG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 10907366
• MDR Text Key: 246071670
• Report Number: 1423395-2020-00035
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 10193489246681
• UDI-Public: 10193489246681
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ60232A
• Device Lot Number: 20EMB142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 56