THERMOFLECT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-22 for THERMOFLECT * manufactured by Industria Manufactureas De Tamaulipas, Sa De C.v..

Event Text Entries

[1312537] Pt arrived in pacu after receiving an mri. Upon arrival in pacu, a 3rd degree burn on the pt's elbow was discovered. The hospital staff was not aware of how the burn occurred, and subsequently started an investigation. The investigation primarily focused on the mri and any products in contact with the pt during the mri, including a thermoflect blanket, a warmed blanket, and an iv entry point near the burn wound. The pt arrived for the mri with the thermoflect blanket having been applied by the anesthesiologist. Thermoflect blankets were not part of the mri protocol and had not been used before. The pt was completely wrapped ("cocooned") in the thermoflect blanket during the mri procedure. Additionally, a warmed blanket was placed over the pt and the standard velcro pt restraints were in place. The mri staff did not witness the burn event and was unaware of the burn until the pt was delivered to pacu. After the investigation, the director of pediatric radiology hypothesized that the positioning of the thermoflect blanket wrapped around the baby created a "looping" or "coiling" of the aluminum layer contained within thermoflect; and when subject to the mri, a current formed that arced and burned the pt's elbow. The director referenced faraday's law of induction as the basis for his hypothesis. The director did test thermoflect lying flat for resistance to transverse current, and it proved to be very resistant - i. E. Non-conductive. However, his hypothesis inferred that the positioning of the blanket allowed a current to develop based on faraday's law. The director did not test thermoflect in a "looped" position and did not recreate the current and arc that he hypothesized. He cited safety concerns for not performing this test. As part of our investigation, we are contacting testing facilities to test the director's hypothesis. We will submit follow-up reports as more information becomes available. According to the director, the pt's burn required stitches and the wound is healing well.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1641118-2009-00001
• MDR Report Key: 1566174
• Date Received: 2009-12-22
• Date of Report: 2009-12-22
• Date of Event: 2009-11-22
• Date Facility Aware: 2009-12-15
• Report Date: 2009-12-22
• Date Reported to FDA: 2009-12-22
• Date Added to Maude: 2009-12-29
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THERMOFLECT
• Generic Name: FME
• Product Code: KME
• Date Received: 2009-12-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INDUSTRIA MANUFACTUREAS DE TAMAULIPAS, SA DE C.V.
• Manufacturer Address: * CHINA, N.L. MX

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2009-12-22