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	Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994); Peeling (1999); Skin Discoloration (2074)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
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 " the area had become red, and she had 2 areas where the skin peeled off, like a sunburn.No oozing, puss, or sores was present.She stated that she had some redness and burns on her back." the cause of the consumer noticing "the area had become red, and she had 2 areas where the skin peeled off, like a sunburn.No oozing, puss, or sores was present.She stated that she had some redness and burns on her back." 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 redness and burns; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.The initial report is being sent late to the fda (on day 32).The report was ready to submit by day 25.The fda was notified that the report would be sent late due to the webtrader cybersecurity vulnerability (notified the fda before day 25).The fda confirmed the mitigation of the cyber security risk past business hours on 27-dec-2021 (day 31).The case is being promptly submitted on the morning of 28-dec-2021 (day 32).Refer to esg help desk ticket number (b)(4).
Event or Problem Description
On (b)(6) 2021, a spontaneous report from the united states was received via telephone from a consumer regarding a (b)(6) female who used a thermacare lower back and hip 8hour l/xl heat wrap.Medical history included asthma.Concomitant products were not provided.On (b)(6) 2021, the consumer topically applied a thermacare lower back and hip 8hour l/xl heat wrap (lot number: ga0105; expiration date 31-aug-2021) to her lower back.It was the first time she used the heat wrap and she applied it over her shirt.After one hour the heat wrap became warm and provided pain relief.After approximately 2 hours of application, the thermacare lower back and hip began to feel extremely hot, and it caused a painful burning sensation.She had the device on for approximately 4 or 5 hours.She went to the restroom at work and removed the wrap and took a picture of the application site.The area had become red, and she had 2 areas where the skin peeled off, like a sunburn.No oozing, puss, or sores was present.She stated that she had some redness and burns on her back.For treatment she applied neosporin and used gauze to protect it.She had not used the device again.As of (b)(6) 2021, one side of the application site was almost healed, her other side had improved but it still was tender, and she had not sought a consult with her doctor.No additional information was provided.The initial report is being sent late to the fda (on day 32).The report was ready to submit by day 25.The fda was notified that the report would be sent late due to the webtrader cyber security vulnerability (notified the fda before day 25).The fda confirmed the mitigation of the cyber security risk past business hours on (b)(6) 2021 (day 31).The case is being promptly submitted on the morning of (b)(6) 2021 (day 32).Refer to esg help desk ticket number (b)(4).

• 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: 13094009
• Report Number: 3007593958-2021-00047
• Device Sequence Number: 2175269
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0105
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 75 KG