MAUDE Adverse Event Report: ANGELINI THERMACARE MUSCLE/JOINT 8HR 3CT; HOT OR COLD DISPOSABLE PACK.

Model Number ThermaCare HeatWraps - Muscle & Joint

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Erythema (1840); Hemorrhage/Bleeding (1888); Urticaria (2278); Skin Tears (2516); Skin Inflammation/ Irritation (4545)

Event Date 08/22/2021

Event Type  Injury  

Event Description

On 24-aug-2021, a spontaneous report from the united states was received via telephone from a consumer regarding a (b)(6) female consumer who was using a thermacare menstrual 8hr heat wrap.Medical history and concomitant product use were not provided.On (b)(6) 2021, the consumer topically applied a thermacare menstrual 8hr heat wrap (lot number and expiration date were unknown) to her lower abdomen area for 5 to 6 hours.The next evening ((b)(6) 2021) she applied a thermacare menstrual 8hr heat wrap to her lower abdomen for an additional 5-6 hours.On (b)(6) 2021, the consumer experienced itching, skin irritation, and pain to the application site area.At one point she scratched the area which caused it to bleed.The area was a little bigger than a pinhead.The bleeding was controlled immediately.For treatment, she used aloe and solarcain on the area which provided little relief.The consumer did not have the packaging or any further medical device specific identifying information.As of (b)(6) 2021, the consumer's scratch was healed, and her symptoms were a little better but had not fully resolved.On 31-aug-2021, additional information was provided by a consumer.Medical history included prior use thermacare for years without issue.On (b)(6) 2021, the consumer had a telemedicine appointment with her health care provider (hcp).The consumer sent pictures of her of her reaction to the hcp.The hcp diagnosed her with the diagnosis of hives and told her to take benadryl (diphenhydramine).She was also prescribed silvadene cream (silver sulfadiazine).Her symptoms were better.Due to her job, she could only take the benadryl at night.She had also been using aloe which was helping.She noted that she would not use the product again.On 01-sep-2021, additional information was provided by a consumer.Medical history included allergies to sulfonamides.The consumer was healthy.No concomitant products were used.The consumer reported that the hcp prescribed silvadene because it was hard for the hcp to say for sure what her reaction was.The hcp gave the diagnosis of hives and did not mention a burn but prescribed silvadene.The consumer thought it was prescribed just in case if it was a burn.The consumer further described her irritation as a reddish irritation, that was painful, tender to the touch, and it itched.She did not think it was hives, but she was not able to say if it was a burn or not.She noted the pain was not a burning pain.Her symptoms were continuing to resolve, and she felt much better.She felt that both the silvadene and the aloe were helping.No additional information was expected to be provided.

Manufacturer Narrative

The root cause cannot be identified.There was limited device-specific information provided, no batch numbers or return samples were available for evaluation.Without batch reference numbers, a manufacturing and technical assessment cannot be completed for the wraps involved in this case.No product quality-related trend was identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures, including in process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for "itching, skin irritation, and pain to the application site area".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE MUSCLE/JOINT 8HR 3CT
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 12512399
• MDR Text Key: 282322374
• Report Number: 3007593958-2021-00035
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733013038
• UDI-Public: 00305733013038
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ThermaCare HeatWraps - Muscle & Joint
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 79