MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-SPECIALTY FACIAL PLASTICS PACK

Catalog Number	DYNJ68844B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Melted (1385)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, during tracheal shave, the patient received a burn from the guarded needle tip bovie from the surgical pack.Burn occurred from the shaft portion of tip.The insulated portion of the electrode "melted" and caused a burn about 3mm in size to the patient.The burn was excised with a blade during the procedure.Facility reports patient was discharged on 1/30.No additional information at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, on (b)(6) 2026, during tracheal shave, the patient received a burn from the guarded needle tip bovie from the surgical pack.

• Brand Name: MEDLINE
• Common Device Name: DBD-SPECIALTY FACIAL PLASTICS PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; three lakes dr; northfield, IL 60093 ; 2173279112
• MDR Report Key: 24472526
• Report Number: 1423395-2026-00032
• Device Sequence Number: 9581342
• Product Code: LRO
• UDI-Device Identifier: 10198459232428
• UDI-Public: 10198459232428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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 Expiration Date: 06/30/2026
• Device Catalogue Number: DYNJ68844B
• Device Lot Number: 25JMH881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown