MAUDE Adverse Event Report: ANGELINI THERMACARE MENSTRUAL 8HR 3+1CT; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Menstrual
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional 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 had 3 blisters at the application area".The cause of the consumer stating she received blisters 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 blisters; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On 05-apr-2022 a spontaneous report from the united states was received from a consumer via telephone regarding a (b)(6) female consumer who used a thermacare muscle/joint 8hr heat wrap.Medical history included high blood pressure, asthma, and a burn blister from a curling wand (resolved).Allergies included flagyl (metronidazole), losartan, lisinopril, and sulfonamides.Concomitant products included an unspecified blood pressure medication and an unspecified inhaler.On (b)(6) 2022, the consumer topically applied a thermacare muscle/joint 8hr heat wrap on her upper back on the right side of her rib cage directly to her skin.On (b)(6) 2022, an unspecified time-period after application of the heat wrap (clarified as "not very long and definitely less than 8 hours"), the consumer experienced the product did not adhere well to her skin.She could feel heat from the heat wrap after application which was not painful.Upon product removal, she noted that she had 3 blisters at the application area.The blisters were smaller than a quarter and were still intact.She did not perform any home treatments and did not see a medical provider.The consumer denied the need for medical evaluation.The consumer expressed that she had to be careful to leave the blisters intact and she did not want to increase her risk of infection by opening the blisters.No further information was provided.

• Brand Name: THERMACARE MENSTRUAL 8HR 3+1CT
• 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: 14120533
• Report Number: 3007593958-2022-00024
• Device Sequence Number: 2355828
• Product Code: IMD
• UDI-Device Identifier: 00305733020449
• UDI-Public: 00305733020449
• Combination Product (Y/N): N
• 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): 04/15/2022

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 Expiration Date: 11/30/2023
• Device Model Number: ThermaCare HeatWraps - Menstrual
• Device Lot Number: EN9996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• 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: UNSPECIFIED BLOOD PRESSURE MEDICATION; UNSPECIFIED INHALER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female