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

Model Number ThermaCare HeatWraps - Lower Back & Hip

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/18/2021

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 " itching and burning sensation at application site".The cause of the consumer stating she had "itching and burning sensation at application site" 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 an itching and burning sensation at application site; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 02-sep-2021, a report from the united states was received via telephone from a consumer regarding a (b)(6) female who used thermacare lower back and hip 8hr heat wrap.Medical history included an allergy to penicillin.She was reported to be healthy.No concomitant products were used.On approximately (b)(6) 2021 (also reported as 2 weeks ago), the consumer topically applied a thermacare lower back and hip 8hr heat wrap (lot number: da2950, expiration date: 21-aug-2022) to her back for an unspecified indication.When she removed the wrap from her back, she noticed her skin was itching and she had a burning sensation.She experienced a rash that appears when she is outside in the heat and when she showers.The area does not always bother her unless she is exposed to increased temperatures.She confirmed the affected area was at the application site of the device.She could not remember if the wrap was intact when she removed it.On (b)(6) 2021, she visited her doctor, and she brought the device with her to the appointment.The doctor prescribed a topical steroid and advised them that this might not go away.As of (b)(6) 2021, her symptoms were ongoing, and she did not have any follow-up appointments scheduled.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR S/M 2CT
• 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 37402
• Manufacturer Contact: steve weisman ; 1100 market street suite 600; chattanooga, TN 37402 ; 9738891600
• MDR Report Key: 12526517
• MDR Text Key: 276350607
• Report Number: 3007593958-2021-00037
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010020
• UDI-Public: 00305733010020
• 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: 09/24/2021

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
• Device Expiration Date: 08/21/2022
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: DA2950
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/24/2021
• Date Device Manufactured: 09/30/2019
• 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
• Patient Age: 14 YR
• Patient Weight: 51