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U.S. Department of Health and Human Services

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

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ANGELINI THERMACARE MENSTRUAL 8HR 3CT; HOT OR COLD DISPOSABLE PACK. Back to Search Results
Lot Number GA0426
Device Problem Insufficient Information (3190)
Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Skin Infection (4544)
Event Date 12/06/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, a spontaneous report was received from the united states via telephone regarding a 32-year-old female who used a thermacare menstrual 8hr heat wrap.The consumer declined to provide information regarding medical history or use of concomitant products, except that she was allergic to lexapro (escitalopram) and she used thermacare approximately a year prior without event.On (b)(6) 2022, the consumer applied a thermacare menstrual 8hr heat wrap to her stomach.On (b)(6) 2022, additional information was provided by a consumer.On (b)(6) 2022, after applying the heat wrap, the consumer received two burns.On (b)(6) 2022, it was clarified that after wearing the product for 5 hours she removed it.When she removed the heat wrap, she had red spots.The area became worse.Subsequently, on (b)(6) 2022 she went to a clinic.She was diagnosed with first and second degree burns and a skin infection which was at the application site.She was prescribed oral cipro (ciprofloxacin) twice daily for 5 days.She was not recommended to follow up unless it became worse.She had not used the heat wrap since (b)(6) 2022.As of (b)(6) 2022, her issues continued.No additional information was provided.
 
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 has " first and second degree burns and a skin infection which was at the application site".The cause of the consumer stating she received burns and a skin infection 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 and skin infection; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
 
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Brand Name
THERMACARE MENSTRUAL 8HR 3CT
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 Key16035448
MDR Text Key306011173
Report Number3007593958-2022-00093
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/20/2022
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 Lot NumberGA0426
Initial Date Manufacturer Received 12/13/2022
Initial Date FDA Received12/22/2022
Date Device Manufactured05/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age32 YR
Patient SexFemale
Patient Weight118 KG
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