MAUDE Adverse Event Report: TOPS MEDICAL ARTICLES INDUSTRY THERMA-MED UNIVERSAL REUSABLE COLD PACK

Model Number TMF10120

Device Problems Excessive Cooling (2932); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 07/31/2015

Event Type  Injury  

Event Description

Customer called and in visiting with her, she indicated she has a severe burn on her leg.She put the cold pack on her leg using the white side for 10 minutes.She did not have the box as she threw the box away.She is an athlete and knows how to use a cold pack.Customer then emailed: i am writing in regard to our conversation on (b)(6) 2015 which addressed the burn i experienced from the therma-med universal reusable cold pack.At your request you will find my documentation of the situation with pictures attached.On (b)(6) 2015 at 6:50am, i experienced some pain in my left knee after exercising and decided to use your product to ice my knee for 10minutes before i needed to get ready for work.After 10 minutes of icing in which i experienced no pain or uncomfortableness, i removed the ice pack to find my leg appearing as seen in pictures 1, 2, and 3.I would like to note that i am an athlete and have utilized countless ice packs, on countless parts of my body, for many years and have never experienced a reaction or burn.I waited a few moments to see if the irritated area would improve and if the pain would alleviate; however this was not the case.Alarmed from the visual appearance and pain being experienced, i contacted my primary care physician who needed to call in a prescription burn cream after viewing the extensive burn on my leg.This caused me to now be late for my job as i needed to pick up this medication and other materials so that i could apply it properly and protect the wounded area.The pain experienced with this was very bad and impaired my ability to move around at my job that day and days to follow.For the next several weeks, i experienced discomfort and pain which interfered in my ability to move around freely, preform physical exercise and be exposed to sunlight which is difficult as it is the summer.My burn interfered in my family vacation as i could only have limited participation at the pool and other areas my leg would be exposed.Additionally, emotionally and psychologically it has affected me as it is a very unattractive wound which is displayed when wearing summer attire.I also was unable to care for my health for several days because i could not engage in aerobic exercises.Despite caring for my burn consistently and as instructed by my medical providers, i still have the aftermath of what your product did to my leg a month later.This does not present as fully healed and i am confident it will take additional months to heal; if it heals completely at all.I have been told by my physicians that this may scar, leaving me with a permanent burn mark.

• Brand Name: THERMA-MED UNIVERSAL REUSABLE COLD PACK
• Type of Device: REUSABLE COLD PACK
• Manufacturer (Section D): TOPS MEDICAL ARTICLES INDUSTRY; south hezou town; qidong city, jiangsu province 22621 5; CH 226215
• MDR Report Key: 5105595
• MDR Text Key: 26823989
• Report Number: 2182780-2015-00010
• Device Sequence Number: 1
• Product Code: IME
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TMF10120
• Device Catalogue Number: TMF10120
• Device Lot Number: UNKNOWN
• 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: 09/25/2015
• Distributor Facility Aware Date: 08/26/2015
• Event Location: Home
• Date Report to Manufacturer: 09/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other