MAUDE Adverse Event Report: COVIDIEN WARMTOUCH; SYSTEM, THERMAL REGULATING

Model Number 5030810

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

Patient Problem Rash (2033)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

The patient reported that she had a rash under her breasts, from her breast to her under arm and her mid thighs.The conclusion was that the rash may have been caused by the warming blanket placed on her prior to surgery.Operating room (or) manager emailed the product information to her so that she could determine what she may be allergic to.

• Brand Name: WARMTOUCH
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 7258798
• MDR Text Key: 99545840
• Report Number: 7258798
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5030810
• Device Catalogue Number: 5030810
• Other Device ID Number: FULL BODY/MULTI ACCESS BLANKE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR