MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BASIC PACK

Catalog Number	DYNJ49627B
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time that this report was opened, it was stated that after approximately 10 minutes of use the cautery device caught fire and the patient experienced "superficial burns to their face and hands." multiple attempts have been made to obtain additional information related to this report.Contact was made with (b)(6), risk manager, who stated that no additional information will be released as the patient involved in this incident has not provided consent to release additional information.At the time this report was opened, it was stated that the account kept the cautery device involved in this incident.However, the facility is unable or unwilling to return the device for evaluation.No additional information related to the incident, the patient, the product, or the procedure has been provided.Due to the reported fire, and in an abundance of caution, this is an mdr reportable event.If additional information becomes available, this report will be reopened and revaluated.
Event or Problem Description
It was reported that, while in use, the cautery device caught fire resulting in superficial burns to the patient's face and hands.

• Common Device Name: BASIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7327243
• Report Number: 1423395-2018-00009
• Device Sequence Number: 19076753
• Product Code: LRO
• UDI-Device Identifier: 10889942026920
• UDI-Public: 10889942026920
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYNJ49627B
• Device Lot Number: 17LK0938
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/09/2018
• 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