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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR LLC. CONAIR; HEATING PAD

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CONAIR LLC. CONAIR; HEATING PAD Back to Search Results
Model Number BM1RLF
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2024
Event Type  malfunction  
Event Description
(b)(6) 2024 - the consumer claims the unit was smoking and the plastic on the unit was very hot.The unit has a 1 year warrenty.The consumer returned the product and accepeted a replacement.
 
Manufacturer Narrative
(b)(6) 2024 - the product has a 1 year warrenty.Therefore, the consumer accepted a replacement and an investigation will not occur.
 
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Brand Name
CONAIR
Type of Device
HEATING PAD
Manufacturer (Section D)
CONAIR LLC.
1 cummings point rd.
stamford CT 06902
Manufacturer Contact
1 cummings point rd.
stratford, CT 06902
MDR Report Key19151704
MDR Text Key341565748
Report Number1222304-2024-00010
Device Sequence Number1
Product Code ISA
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 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberBM1RLF
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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