MAUDE Adverse Event Report: ANGELINI THERMACARE NECK/SHOULDER/WRIST 8HR 3CT; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Neck, Wrist & Shoulder
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/29/2022
Type of Reportable Event	Serious Injury
Additional 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 was 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 or Problem Description
On 09-feb-2022, a spontaneous report from the united states was received from a consumer via telephone regarding a (b)(6) female patient who used thermacare neck/shoulder/wrist 8hr heat wrap.On 16-feb-2022, additional information was provided by the consumer.Medical history included type ii diabetes, arthritis, high cholesterol, and prior use of thermacare for years without issue.Concomitant products included amoxicillin.On (b)(6) 2022, the consumer topically applied a thermacare neck/shoulder/wrist 8hr heat wrap (expiration date and lot number not provided) directly to the skin of her neck for arthritis.On (b)(6) 2022, within an hour of taking the patch off (after wearing it for 6 hours), she had burns and blistering on her neck.Her neighbor came over after she mentioned it bothered her neck.When she took the product off the neighbor noticed the area was red and blistered.On unspecified dates, the consumer saw her doctor.The doctor applied silver sulfadiazine cream and bandaged the area.The doctor also wrote a prescription for the silver sulfadiazine cream.During her second visit, the last week (relative to (b)(6) 2022), the doctor told her to keep the area clean, dry, and to continue to apply the cream.The doctor was worried about infection and scarring so she was keeping an eye on it.The consumer missed 8 days of work due to the incident.The doctor told her she could return to work on (b)(6) 2022.The product was discarded, and provision of further device details were not possible.As of (b)(6) 2022, the consumer's redness was better, and the blisters had dried up, but she still could see spots where the blisters were located.She realized it would take time to completely heal.She continued to use silver sulfadiazine and aloe vera as well.She was not going to follow up with her health care practitioner until (b)(6) 2022.No additional information was provided.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 8HR 3CT
• Common Device Name: 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: 13653169
• Report Number: 3007593958-2022-00010
• Device Sequence Number: 5974522
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 00305733015025
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Neck, Wrist & Shoulder
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BABY ASPIRIN (ACETYLSALICYLIC ACID); CRESTOR (ROSUVASTATIN); INSULIN; METFORMIN; OCUVITE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 91 KG