MAUDE Adverse Event Report: SOMACARE HEAT PACKS; PACK, HOT OR COLD, DISPOSABLE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 09/08/2020

Event Type  Injury  

Event Description

I used a somacare heat pack per the directions on the pack.Not against bare skin, 2 layers of shirt between my back and the pack.Not more than 20 minutes, i set an alarm for 20 minutes "before" starting the pack.I use that timer for naps and did for this as well as usual.The timer went off and i woke up and got off of the hot pack.The next day my wife saw a large blister on my back so we went to an urgent care.The urgent care nurse wrote that i fell asleep on the pack which is true but failed to mention that i had an alarm set and that i got up when the alarm went off.I was on that pack under 20 minutes and got a 3rd degree burn.The burn required multiple visits to my doctor and the local wound center, i still have a very ugly scar on my back.I contacted the company about this through an attorney and they apparently think that it is a joke when an elderly person is burned by their product that claims to be safe.They wouldn't even cover the medical costs to treat the wound that their product caused.Their product is not safe as the pictures demonstrate.I hope that you will do something to mitigate this issue before more elderly get injured as i did.This is a dangerous product and lacks sufficient warnings and instructions on the devices to safely use them.Somacare.Fda safety report id# (b)(4).

• Brand Name: SOMACARE HEAT PACKS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• MDR Report Key: 11331604
• MDR Text Key: 231979499
• Report Number: MW5099369
• 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: 02/10/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 111