MAUDE Adverse Event Report: TOPS MEDICAL ARTICLES INDUSTRIES HOT N' COLD PAD/THERMIPAQ CLAY THERAPY HOT COLD PAIN RELIEF WRAP; HOT COLD PACK

Model Number TPF201RB

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 09/27/2015

Event Type  Injury  

Event Description

An end-user sustained an injury while using a thermipaq clay therapy hot cold pain relief wrap.The end-user was using this product in its ordinary course, following all directions, when she sustained serious burns to her upper arm.User intends to pursue a claim for injuries sustained due to the defective product.

• Brand Name: HOT N' COLD PAD/THERMIPAQ CLAY THERAPY HOT COLD PAIN RELIEF WRAP
• Type of Device: HOT COLD PACK
• Manufacturer (Section D): TOPS MEDICAL ARTICLES INDUSTRIES; south hezou town; qidong city, jiangsu 22262 15; CH 2226215
• MDR Report Key: 5816887
• MDR Text Key: 50290324
• Report Number: 3005182235-2016-00017
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TPF201RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2016
• Distributor Facility Aware Date: 07/07/2016
• Date Report to Manufacturer: 07/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other