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

Catalog Number DYNJ49627B

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 02/02/2018

Event Type  malfunction  

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 Description

It was reported that, while in use, the cautery device caught fire resulting in superficial burns to the patient's face and hands.

• Type of Device: BASIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093 ; 2249311458
• MDR Report Key: 7327243
• MDR Text Key: 102188859
• Report Number: 1423395-2018-00009
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942026920
• UDI-Public: 10889942026920
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ49627B
• Device Lot Number: 17LK0938
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• 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): Other