MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS FORCE FX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number FORCEFX-8CAS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); No Code Available (3191)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-operatively, the patient had a blister and rash in the gluteal fold.Consultation with a cosmetic surgeon recommended continuous local care and there was no indication for antibiotic therapy as long as the erythema does not progress and the patient is apyretic.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9717869
• MDR Text Key: 182801773
• Report Number: 3006451981-2020-00023
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002637
• UDI-Public: 10884524002637
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEFX-8CAS
• Device Catalogue Number: FORCEFX-8CAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1