MAUDE Adverse Event Report: ANGELINI THERMACARE HEAT WRAP UNSPECIFIED; HOT OR COLD DISPOSABLE PACK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Urticaria (2278); Blister (4537)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

The root cause can not be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports "blistering".The cause of the consumer stating she received blisters is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for a blister and skin irritation; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On (b)(6) 2021, a spontaneous report from the (b)(6) was received from a consumer regarding a female (age and ethnicity were not provided) consumer who was using an unspecified thermacare heat wrap.The thermacare lot number and expiration date were not provided.Medical history included back pain.Concomitant products were not provided.On (b)(6) 2021, the consumer topically applied one thermacare heat wrap to her back for back pain for less than two hours while she was at work.At 3:00, on the same day, the consumer came home from work and took a shower.Approximately at 7:30, she felt a welt on her back where she placed the heat wrap.She had a trip planned to leave the next morning.She was in severe pain, but she still went.She kept the area covered with medicine.Due to it blistering and being unable to walk for a long period because of it rubbing on her clothes, she had to cut her trip short and fly home several days earlier.She obtained a legal consult.She reported there was a problem with the product.Additional product identifiers were not provided.No additional information was provided.

• Brand Name: THERMACARE HEAT WRAP UNSPECIFIED
• Type of Device: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 1100 market street suite 600; chattanooga TN 37042
• Manufacturer Contact: steve weisman ; 1100 market street suite 600; chattanooga, TN 37402 ; 9738891600
• MDR Report Key: 12217876
• MDR Text Key: 263550774
• Report Number: 3007593958-2021-00027
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2021

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention