MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline Industries, Inc.; CAUTERY BLADE IN MINOR PACK KIT

Model Number	DYNJ57889A
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch received from fda ((b)(4)) on 6/10/2020 for medwatch that the customer filed related to a cautery blade that touched a metal retractor during a surgical procedure.Patient incurred a small burn.Upon further investigation and additional information received from the facility, the reporter states, "a small burn was noted distal to the incision with an approximate size of a pencil eraser.Derma-bond was placed at the site".The reporter is unable to report at this time how the patient is doing.There are no pictures, and the sample is not available for return and evaluation.Therefore, a true root cause could not be determined at this time.There is no further information at this time.Due to the report of a burn, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a cautery blade touched the metal retractor during a surgical procedure.Patient incurred a small burn.

• Brand Name: Medline Industries, Inc.
• Common Device Name: CAUTERY BLADE IN MINOR PACK KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10190147
• Report Number: 1423395-2020-00012
• Device Sequence Number: 886489
• Product Code: FDE
• UDI-Device Identifier: 10888277766808
• UDI-Public: 10888277766808
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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
• Operator of Device: Health Professional
• Device Model Number: DYNJ57889A
• Device Catalogue Number: DYNJ57889A
• Device Lot Number: 20BLA351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/24/2020
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 79