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

Lot Number LGA0411

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

This spontaneous report was received from a consumer in the united states via telephone on 18-nov-2022.A follow-up with the consumer via telephone was attempted on 22-nov-2022 to obtain additional information but the consumer could not be reached.The consumer is a female of unknown age.Her past medical history is significant for an unspecified skin condition and an unspecified injury.Concomitant medications or supplements were unspecified.Her allergies were unknown.On an unspecified date, the consumer had an unspecified injury and was using an ice pack before using the thermacare heatwraps back pain therapy l-xl 2ct.She reported a 3rd degree burn with circles/dots.She also stated that she had a skin condition and wasn't certain if it was due to the product, the ice pack, or her skin condition.She later added that she went to the hospital for the burn.No treatment information was available.The outcome for third degree burns and skin condition was unspecified.No further details were disclosed.

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 receiving a "3rd degree burn with circles/dots".The cause of the consumer stating she received a 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 burn; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE LOWER BACK AND HIP 8HR L/XL
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• 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: 15965051
• MDR Text Key: 305325926
• Report Number: 3007593958-2022-00084
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• 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: 12/08/2022

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 Lot Number: LGA0411
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/12/2022
• Date Device Manufactured: 05/24/2022
• 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