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

Lot Number EE3301

Device Problem Excessive Heating (4030)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/15/2022

Event Type  Injury  

Manufacturer Narrative

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 " her back on the right side had large burns which ended up blistering".The cause of the consumer stating she received burns that blistered 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 burn and blisters: a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 16-may-2022, a spontaneous report from the united states was received from a consumer regarding a female consumer (age not reported) who used a thermacare low back and hip heat wrap.Medical history included use of thermacare for years without issue.Concomitant products were not provided.On 15-may-2022, the consumer used a thermacare lower back and hip wrap to her back for an unspecified indication.On 15-may-2022, the consumer experienced the left side of the patch cooled down, but the right side never seemed to have maintained its heat.She pulled the heat wrap off as soon as she realized that it was burning her.Her back on the right side had large burns which ended up blistering.No additional information was provided.

• 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 ; 4237178579
• MDR Report Key: 14593926
• MDR Text Key: 293278723
• Report Number: 3007593958-2022-00035
• 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: Other
• Type of Report: Initial
• Report Date: 06/02/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Lot Number: EE3301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female