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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGELINI THERMACARE MENSTRUAL; HOT OR COLD DISPOSABLE PACK.

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ANGELINI THERMACARE MENSTRUAL; HOT OR COLD DISPOSABLE PACK. Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Burn(s) (1757); Scar Tissue (2060)
Event Type  Injury  
Event Description
On (b)(6) 2022, a spontaneous report was received via social media regarding a thermacare menstrual 8hr heat wrap.Medical history included stomach cramps.Concomitant products were not provided.On an unspecified date, the consumer applied a thermacare menstrual 8hr heat wrap for stomach cramps.On an unspecified date, after applying the heat wrap, the heat wrap "broke open and burnt her tummy".She had a scar at the site.No additional information was provided.
 
Manufacturer Narrative
The root cause cannot be identified.There is limited device specific information provided, no batch number was available for evaluation.Without a batch reference number, 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.
 
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Brand Name
THERMACARE MENSTRUAL
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
4234142221
MDR Report Key16053236
MDR Text Key306240083
Report Number3007593958-2022-00098
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 Non-Healthcare Professional
Type of Report Initial
Report Date 12/26/2022
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? Yes
Device Operator Lay User/Patient
Initial Date Manufacturer Received 12/16/2022
Initial Date FDA Received12/27/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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