MAUDE Adverse Event Report: PFIZER THERMACARE HEAT WRAP NECK, WRIST, SHOULDER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Nerve Damage (1979); Pain (1994); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 08/27/2013

Event Type  No Answer Provided  

Event Description

I used a thermacare heat wrap on my right leg from below my knee to my hip and hip from my leg to my waist on (b)(6) 2013 for pain and rec'd 2nd degree burns and nerve ending damage.The instructions says you can leave the wrap on for 8 hrs, i only left it on approx 20-30 mins on any area.I have had severe pain, blisters and unable to have clothing on the area w/o pain since then.I have also not been able to work or do my normal activities.I called pfizer about the burns, but was advised that there was nothing in the wrap that could cause a burn and that the wrap said it was for neck and shoulder and i used it for my leg and hip.This product should be taken off the market.I do have pictures if you would like me to forward them on to you.Since talking with pfizer, i have done some research on the web only to find that there have been others burned by this product.This product caused deep burns, especially the areas of the metal disc of the product.The pictures that i have taken show the marks of the disc.After 4 1/2 months, i still have severe pain and the burn marks are still not totally healed.This product in my opinion are extremely dangerous.I did check the sell by date on the package and the date was 2014.Reason for use: to relieve pain in my right leg and hip.

• Brand Name: THERMACARE HEAT WRAP NECK, WRIST, SHOULDER
• Type of Device: THERMACARE HEAT WRAP NECK, WRIST, SHOULDER
• Manufacturer (Section D): PFIZER
• MDR Report Key: 3581064
• MDR Text Key: 16219769
• Report Number: MW5033891
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/13/2014

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?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 78 YR
• Patient Weight: 67