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

Lot Number EJ9272 10/13

Device Problem Excessive Heating (4030)

Patient Problems Purulent Discharge (1812); Pain (1994); Scar Tissue (2060); Full thickness (Third Degree) Burn (2696)

Event Date 01/11/2022

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 (b)(6) 2022, a spontaneous report from (b)(6) was received from a consumer via email regarding a female consumer (age not provided) who used a robax lower back and hip heat wrap.Medical history and concomitant products were not provided.On an unspecified date, the consumer topically applied a robax lower back and hip heat wrap (lot number: fj9272; expiration date: sep-2023) over her pajamas to her back for an unspecified indication.On an unspecified date, after applying the product, she was "severely injured." she had a third-degree burn (consumer reported, not verified by health professional).She was in so much pain.She was in bed for two weeks because when she moved it would rub against her clothes.The healing process was extremely painful since it was always oozing and getting stuck to her clothes.On an unspecified date, she visited her doctor (details regarding the visit were not provided).As of (b)(6) 2022, the consumer was noted to have a huge black scar on her back.The consumer was obtaining advice from a lawyer.Further information was not provided and not expected due to possible legal action.

Manufacturer Narrative

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 "was severely injured -she had a third degree burn".The cause of the consumer reporting 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 a burn; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On (b)(6) 2022, a spontaneous report from canada was received from a consumer via email regarding a female consumer (age not provided) who used a robax lower back and hip heat wrap.Medical history and concomitant products were not provided.On an unspecified date, the consumer topically applied a robax lower back and hip heat wrap (lot number: fj9272; expiration date: sep-2023) over her pajamas to her back for an unspecified indication.On an unspecified date, after applying the product, she was "severely injured." she had a third-degree burn (consumer reported, not verified by health professional).She was in so much pain.She was in bed for two weeks because when she moved it would rub against her clothes.The healing process was extremely painful since it was always oozing and getting stuck to her clothes.On an unspecified date, she visited her doctor (details regarding the visit were not provided).As of (b)(6) 2022, the consumer was noted to have a huge black scar on her back.The consumer was obtaining advice from a lawyer.Further information was not provided and not expected due to possible legal action.On (b)(6) 2022, additional information was received from the consumer.The robax lower back and hip heat wrap was used for a back injury which occurred when the consumer was making her bed on (b)(6) 2022.She used the robax for her back.The consumer noted that she could not walk.She was "over medication." her burn was getting better but it still hurt.

• Brand Name: ROBAX HEATWRAP 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: 13806423
• MDR Text Key: 287392189
• Report Number: 3007593958-2022-00014
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

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 Expiration Date: 09/01/2023
• Device Lot Number: EJ9272 10/13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2022
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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