MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK AND HIP; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0553

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 03/27/2023

Event Type  Injury  

Event Description

On 31-mar-2023, a spontaneous report from the united states was received via email regarding a female of unknown age who used a thermacare lower back and hip heat wrap.On (b)(6) 2023, the consumer applied a thermacare lower back and hip heat wrap.After wearing the heat wrap for 8 hours, when she took it off, she noticed a pain in the middle of the back where one of the coils or heat cells were.On unspecified date(s) the consumer went to an emergency room twice for her pain.She noted she was not able to lean backwards due to the pain.The pain was a null, dull, nagging pain which was uncomfortable.As of 31-mar-2023, she still had the pain was not subdued.No further information was provided.

Manufacturer Narrative

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 " pain in the middle of the back".The cause of the consumer stating "pain in the middle of the back" are 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 pain and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE LOWER BACK AND HIP
• Type of Device: 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 ; 4234142221
• MDR Report Key: 16786598
• MDR Text Key: 313738704
• Report Number: 3007593958-2023-00023
• Device Sequence Number: 1
• Product Code: IMD
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: GA0553
• Date Manufacturer Received: 03/31/2023
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female