MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCETRIAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FORCETRIAD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, two days post-procedure, when they removed the compression stockings of the patient they noticed a small second degree burn on the inner back of the calf of the patient.They treated the burn with silvederma and linitul.They also noted that they do not know what equipment was used during the surgery and they did not have any problems with any equipment in subsequent surgeries.

• Brand Name: FORCETRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7540509
• Report Number: 1717344-2018-00745
• Device Sequence Number: 11371594
• Product Code: GEI
• UDI-Device Identifier: 10884521129498
• UDI-Public: 10884521129498
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K102913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FORCETRIAD
• Device Catalogue Number: FORCETRIAD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/24/2018
• 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: Required Intervention
• Patient Age: 41 YR