MAUDE Adverse Event Report: TOPS MEDICAL ARTICLES INDUSTRIES NANTONG INC THERAMED; RITE AID INSTANT COLD THERAPY WRAP

Model Number TMF0362277

Device Problem Temperature Problem (3022)

Patient Problem Injury (2348)

Event Date 12/13/2015

Event Type  Injury  

Event Description

Per the lawsuit: purchase date of cold wrap (b)(6) 2015 - said packaging did not provide any warnings concerning the use, application, and extent of time the device should remain in place and/or any harm which could arise from any allergy use of said product.While using the product (same day of purchase) in accordance with its intended use & pursuant to the written instructions set forth on the aforesaid label, was caused to suffer and sustain severe and permanent bodily injuries.The wrap caused severe and serious burns to the skin on the user's left leg, leaving her with severe, serious, disfiguring and permanent scarring.Item number of device involved with event could not be verified.

Event Description

Item number was determined to be tmf0362277.

• Brand Name: THERAMED
• Type of Device: RITE AID INSTANT COLD THERAPY WRAP
• Manufacturer (Section D): TOPS MEDICAL ARTICLES INDUSTRIES NANTONG INC; south hezoucaojia town; qidong city; jiangsu, 22262 15; CH 2226215
• MDR Report Key: 8258840
• MDR Text Key: 133471507
• Report Number: 3012316249-2019-00002
• Device Sequence Number: 1
• Product Code: IME
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/22/2019,01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TMF0362277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2019
• Distributor Facility Aware Date: 01/02/2019
• Date Report to Manufacturer: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other