MAUDE Adverse Event Report: KLS - MARTIN L. P. SONICWELD TX301

Model Number TX301

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

Patient Problem Alteration In Body Temperature (2682)

Event Date 04/20/2018

Event Type  Injury  

Event Description

Pt underwent midfacial fractures surgery on (b)(6) 2017.Postoperatively, she has had fever on (b)(6) 2017, temperature maximum of 102.6 degrees.She denies any cough, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea or dysuria.

• Brand Name: SONICWELD TX301
• Type of Device: SONICWELD TX301
• Manufacturer (Section D): KLS - MARTIN L. P.
• MDR Report Key: 7457641
• MDR Text Key: 106663309
• Report Number: MW5076683
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: TX301
• Device Catalogue Number: 234412
• Device Lot Number: 12334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 73