MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR L/XL 2CT; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Superficial (First Degree) Burn (2685)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause cannot 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 "redness, pain, and it looked like a burn on her back above the waist." the cause of the consumer noticing "redness, pain, and it looked like a burn on her back above the waist." 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 burns or other skin irritations.This is an adverse event for a burn, red, and hot to touch; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On (b)(6) 2021, a spontaneous report from the united states was received via telephone regarding an (b)(6) female consumer who was using thermacare lower back & hip 8hr l/xl.Medical history was not reported.The consumer was a non-smoker.Concomitant products included unspecified vitamins and unspecified supplements.On (b)(6) 2021, the consumer topically applied a thermacare lower back & hip 8hr l/xl heat wrap on her back for 6 hours for an unspecified indication.After 6 hours she had redness, pain, and it looked like a burn on her back above the waist.On (b)(6) 2021, she went to her primary doctor and was told it was some kind of burn.For treatment she was given a prescription for 1% silver sulfadiazine cream.She had not used the product again.The consumer noted that the picture on front of the box showed the heat wrap being applied to skin and the back of the box reads to apply the heat wrap over clothing.She thought it was false advertising.As of 17-nov-2021, follow up attempts have been unsuccessful in establishing contact with the reporter to obtain additional information.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• Common Device Name: 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 37402
• Manufacturer Contact: steve weisman ; 1100 market street suite 600; chattanooga, TN 37402 ; 9738891600
• MDR Report Key: 12975959
• Report Number: 3007593958-2021-00046
• Device Sequence Number: 20031106
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/01/2024
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 62 KG