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

Catalog Number	DYNJ904189A
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was a reported that during a procedure the cautery device arced, resulting in a flame that burned a patient.The patient experienced a "superficial burn to the inside of the right cheek and right side of tongue," requiring hospitalization for three days.Treatment for the burn was not reported.The patient was under general anesthesia during the reported event but the incident did not cause the procedure to run longer than expected.After discharge from the hospital the patient has not required additional follow-up care or medical intervention.The actual sample of the insulated blade was returned for investigation, however the cautery pencil was not returned.The returned insulated blade was noted to have heavy carbon build up on the tip and the opaque plastic insulation was worn on the edge of the insulated blade.A companion sample of the cautery pencil was used for evaluation and the customer reported issue was not confirmed.The cautery pencil and the returned insulated blade performed nominal under varied settings and durations and did not duplicate the reported issue or cause a burn.Due to the reported incident and the need for hospitalization, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was a reported that during a procedure the cautery device arced, resulting in a flame that burned a patient.

• Common Device Name: LOCAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7269870
• Report Number: 1423395-2018-00002
• Device Sequence Number: 1367946
• Product Code: LRO
• UDI-Device Identifier: 10889942685011
• UDI-Public: 10889942685011
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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: DYNJ904189A
• Device Lot Number: 17TB0518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/14/2018
• 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: Hospitalization
• Patient Age: 2 YR
• Patient Weight: 16