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

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

Event Description

On 28-jan-2022 a report from a consumer was received from the fda ((b)(4)) regarding a female patient (age not provided) who used a thermacare back pain therapy heat wrap.On 01-feb-2022, additional information was received from a consumer.Medical history and concomitant products were declined.On (b)(6) 2021, the consumer topically applied a thermacare back pain therapy heat wrap (lot number and expiration date not provided) to the back for an unspecified indication.On (b)(6) 2021, an unspecified time after applying the product, it burned their skin.It was clarified that the consumer applied the product to her lower back during a church service and when she returned home, she removed the product.When she removed the product, she noticed that there was blistering present.Due to her symptoms, she was evaluated by her dermatologist.It was determined that she experienced a "chemical burn" from use of the product.She used unspecified analgesia to treat her ongoing pain she experienced.The area finally healed on its own after 2 months.She was upset that she had two permanent scars on her lower back where the product was applied.She confirmed that she discarded the product after her use and was not able to provide any further information about the specific product she used.No additional information was provided.

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

Event Description

On (b)(6) 2022 a report from a consumer was received from the fda (mw5105901) regarding a female patient (age not provided) who used a thermacare back pain therapy heat wrap.On 01-feb-2022, additional information was received from a consumer.Medical history and concomitant products were declined.On (b)(6) 2021, the consumer topically applied a thermacare back pain therapy heat wrap (lot number and expiration date not provided) to the back for an unspecified indication.On (b)(6) 2021, an unspecified time after applying the product, it burned their skin.It was clarified that the consumer applied the product to her lower back during a church service and when she returned home, she removed the product.When she removed the product, she noticed that there was blistering present.Due to her symptoms, she was evaluated by her dermatologist.It was determined that she experienced a "chemical burn" from use of the product.She used unspecified analgesia to treat her ongoing pain she experienced.The area finally healed on its own after 2 months.She was upset that she had two permanent scars on her lower back where the product was applied.She confirmed that she discarded the product after her use and was not able to provide any further information about the specific product she used.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: 13552856
• MDR Text Key: 286085205
• Report Number: 3007593958-2022-00008
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2022

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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