MAUDE Adverse Event Report: ANGELINI THERMACARE HEATWRAP; HOT OR COLD DISPOSABLE PACK.

Lot Number EE3302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 11/15/2021

Event Type  Injury  

Event Description

On 16-nov-2021, a spontaneous report from the united states was received from a consumer via email regarding a (b)(6) consumer who was using an unspecified thermacare heat wrap.Medical history included prior use of thermacare heat wraps without event.The consumer was healthy.Concomitant products were not provided.On an unspecified date, the consumer topically applied an unspecified thermacare heat wrap (lot number ee3302; expiration date 31-jul-2023) to her lower abdomen and then she laid down to take a nap.On an unspecified date, one hour after applying the thermacare heat wrap, the consumer woke up to extreme pain.She removed the heat wrap immediately and it looked like a burn.She found bright red spots in the same pattern as the heating spots.Within the hour, the red spots turned into blisters which were very painful.It was also reported by the next day, the area had a couple of blisters.On an unspecified date she called her primary care provider who advised to use burn cream and to apply neosporin on the blisters once they opened.She was also advised to come in for an appointment if the wound worsened or if it was looking like it was getting infected.As of on (b)(6) 2022, the area healed up well and she did not need to go in for medical attention.She did have a scar at the burn site which she was not sure if it would ever go away.No additional information was provided.

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 she "found bright red spots in the same pattern as the heating spots.Within the hour, the red spots turned into blisters which were very painful".The cause of the consumer stating she "found bright red spots in the same pattern as the heating spots.Within the hour, the red spots turned into blisters which were very painful" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.This is an adverse event for the consumer receiving blisters from the product.A 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 she "found bright red spots in the same pattern as the heating spots.Within the hour, the red spots turned into blisters which were very painful".The cause of the consumer stating she "found bright red spots in the same pattern as the heating spots.Within the hour, the red spots turned into blisters which were very painful" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.This is an adverse event for the consumer receiving blisters from the product.A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 16-nov-2021, a spontaneous report from the united states was received from a consumer via email regarding a (b)(6) consumer who was using an unspecified thermacare heat wrap.Medical history included prior use of thermacare heat wraps without event.The consumer was healthy.Concomitant products were not provided.On an unspecified date, the consumer topically applied an unspecified thermacare heat wrap (lot number ee3302; expiration date 31-jul-2023) to her lower abdomen and then she laid down to take a nap.On an unspecified date, one hour after applying the thermacare heat wrap, the consumer woke up to extreme pain.She removed the heat wrap immediately and it looked like a burn.She found bright red spots in the same pattern as the heating spots.Within the hour, the red spots turned into blisters which were very painful.It was also reported by the next day, the area had a couple of blisters.On an unspecified date she called her primary care provider who advised to use burn cream and to apply neosporin on the blisters once they opened.She was also advised to come in for an appointment if the wound worsened or if it was looking like it was getting infected.As of on (b)(6) 2022, the area healed up well and she did not need to go in for medical attention.She did have a scar at the burn site which she was not sure if it would ever go away.No additional information was provided.

• Brand Name: THERMACARE HEATWRAP
• 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: 13311371
• MDR Text Key: 285426322
• Report Number: 3007593958-2021-00054
• 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: 01/18/2022

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: 07/31/2023
• Device Lot Number: EE3302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 91 KG