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

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Ulcer (2274); Partial thickness (Second Degree) Burn (2694)
Date of Event	08/03/2022
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.Thereview of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports " she received blisters after wearing the wrap".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 blisters; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On 12-aug-2022, a spontaneous report from the united states was received via telephone regarding a 30-year-old female who used a thermacare lower back and hip 8hr l/xl heat wrap.Medical history included an unspecified thyroid disorder and prior use of thermacare for years without event.Concomitant products included synthroid (levothyroxine).On (b)(6) 2022, the consumer topically applied a thermacare lower back and hip 8hr l/xl heat wrap to her lower abdomen because she should not find the menstrual cramp product.Six hours after wearing the product, she removed it and noticed that the site was red and irritated.The next morning, she noticed two painful blisters.She could line up the blister areas with the device.One blister was just right from the center that was the size of a half dollar.The other blister was just left of the center and the size of a nickel.Two days later the blisters ruptured.Her father, who was a physician, looked at the area.She stated she had a pretty bad second degree burn from the wrap.On (b)(6) 2022, she started treatment with prescription silvadene (silver sulfadiazine) applied to the area twice a day.She was instructed to wear loose fitted clothing to keep it from rubbing on the area.The area was deep and scabbed over after 2 days of treatment.It was healing but the larger blister area was concave.Both blister sites were red, pink, and painful.Her pain was a 3 out of 10.She felt the pain was a would healing type of pain.No additional information was provided.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 15348250
• Report Number: 3007593958-2022-00053
• Device Sequence Number: 14736099
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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 Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0351
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNTHROID (LEVOTHYROXINE)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 82 KG