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

Lot Number LGA0378

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994); Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, the consumer topically applied a thermacare lower back and hip l/xl heat wrap which was applied to her lower back on the left side on top of her underwear for 20 minutes and on top of her skin by 10 minutes.On (b)(6) 2022, 30 minutes after applying the heat wrap, she experienced 4 to 6 quarter sized blister burn marks on her skin from the coils.The heat wrap burned her through her underwear.The burn marks turned into blisters.Subsequently, she took the heat wrap off.She had gigantic blisters which resulted in her going to the doctor.The doctor stated she had near second-degree burns.She clarified she had second-degree burns.She was advised to use a vaseline ointment or desonide cream that she had on hand.The blisters scabbed over.The scabs were thick, and it took weeks for them to fall off.She had a difficult time working, sitting, and moving freely due to the scabs restricting these activities.They were very red, painful, and they would bleed when she removed them.She used tylenol (acetaminophen) for pain and applied the cream daily to help the scabs.The scabs fell off after a few weeks.It had almost taken two months for them to heal.She had divots in her skin and permanent scars that were still red.She had scars for life.She recalled that when she took the product off and put it back in the box, it took 5 days to cool down.As of 20-sep-2022, she was still recovering.

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 "quarter sized blister burn marks on her skin".The cause of the consumer stating she received "quarter sized blister burn marks on her skin" 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; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

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 "quarter sized blister burn marks on her skin".The cause of the consumer stating she received "quarter sized blister burn marks on her skin" 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; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.On 24-oct-2022, bridges consumer healthcare received additional information from angelini who received the information on 13-oct-2022.The verbatim of the information is as follows: 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 "quarter sized blister burn marks on her skin".The cause of the consumer stating she received "quarter sized blister burn marks on her skin" is inconclusive since review of records does not provide evidence to support defective product.Evaluation of the consumer returned sample by the manufacturing site did not show any obvious defects.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; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

Aug-2022, the consumer topically applied a thermacare lower back and hip l/xl heat wrap which was applied to her lower back on the left side on top of her underwear for 20 minutes and on top of her skin by 10 minutes.On (b)(6) 2022, 30 minutes after applying the heat wrap, she experienced 4 to 6 quarter sized blister burn marks on her skin from the coils.The heat wrap burned her through her underwear.The burn marks turned into blisters.Subsequently, she took the heat wrap off.She had gigantic blisters which resulted in her going to the doctor.The doctor stated she had near second-degree burns.She clarified she had second-degree burns.She was advised to use a vaseline ointment or desonide cream that she had on hand.The blisters scabbed over.The scabs were thick, and it took weeks for them to fall off.She had a difficult time working, sitting, and moving freely due to the scabs restricting these activities.They were very red, painful, and they would bleed when she removed them.She used tylenol (acetaminophen) for pain and applied the cream daily to help the scabs.The scabs fell off after a few weeks.It had almost taken two months for them to heal.She had divots in her skin and permanent scars that were still red.She had scars for life.She recalled that when she took the product off and put it back in the box, it took 5 days to cool down.As of (b)(6) 2022, she was still recovering.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL
• 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: 15596662
• MDR Text Key: 301662053
• Report Number: 3007593958-2022-00066
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: LGA0378
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2022
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 113 KG