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

Model Number ThermaCare HeatWraps - Lower Back & Hip

Device Problem Excessive Heating (4030)

Patient Problems Pain (1994); Chills (2191); Urticaria (2278); Partial thickness (Second Degree) Burn (2694)

Event Date 08/12/2022

Event Type  Injury  

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 she received "red welts and blisters on her back which were the size of silver dollars.She had severe pain and also had chills.She had a severe burn." the cause of the consumer stating she received a "severe burn" 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; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 17-aug-2022, a spontaneous report from the united states was received via email regarding a 49-year-old female who used a thermacare lower back and hip l/xl heat wrap.Medical history included backpain and diabetes type ii.Concomitant products included metformin and glipizide.On (b)(6) 2022, the consumer applied a thermacare lower back and hip l/xl heat wrap for back pain over a tank top.After wearing the heat wrap for 6 to 7 hours, the consumer experienced a burning sensation and irritation.She took off the wrap.The consumer's relative looked at the device site and noted there were red welts and blisters on her back which were the size of silver dollars.She had severe pain and chills.She had a severe burn.On (b)(6) 2022, the consumer spoke with her primary medical doctor and provided pictures.She was prescribed oral keflex (cephalexin) and silvadene (silver sulfadiazine).On (b)(6) 2022, it was the first day she felt up to getting around because of the pain.Her symptoms were still present, and she thought she might be calling her doctor.As of (b)(6) 2022, the consumer was still applying silvadene and taking keflex.The area was slowing healing.No additional information was provided.On 26-aug-2022, additional information was received.Additional medical history included charcot foot with neuropathy resulting in a disability.She still had lots of burning and irritation at the application site.She clarified that she originally had three silver dollar sized blisters that all popped by (b)(6) 2022 and turned into scabs on (b)(6) 2022.She continued to have welt looking areas that turned from red to purple in color.The chills she experienced resolved by (b)(6) 2022.She experienced itching at the site which started on (b)(6) 2022.She hopes that meant she was healing.She had two days left of her keflex therapy and was still applying silvadene twice daily as directed by her doctor.She noted that she had not been evaluated in person and had been corresponding with her doctor via a patient portal.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; ablany 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: 15348262
• MDR Text Key: 299165245
• Report Number: 3007593958-2022-00054
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0237
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLIPIZIDE; LYRICA (PREGABALIN); METFORMIN; UNSPECIFIED ANTIDEPRESSANT; UNSPECIFIED THYROID MEDICATION
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female