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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; HEATING PAD
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CONAIR CORPORATION CONAIR CORPORATION; HEATING PAD Back to Search Results
Model Number HP01XF
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/20/2020
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2020: the consumer accepted a replacement product.Therefore the product will not be returned to the manufacturer for an investigation.
 
Event Description
On (b)(6) 2020: the consumer claims that the product exploded.The consumer accepted a replacement product.
 
Manufacturer Narrative
8/20/2020 - the consumer accepted a replacement product.Therefore the product will not be returned to the manufacturer for an investigation.4/27/2021 - per the fda's request, submitted a supplemental mdr that does not include the age and dob.It was also discovered the common device name (bmi scale) is incorrect.Should have been a heating pad.I made the correction.
 
Event Description
7/20/2020 - the consumer claims that the product exploded.The consumer accepted a replacement product.4/27/2021 - per the fda's request, submitted a supplemental mdr that does not include the age and dob.
 
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Brand Name
CONAIR CORPORATION
Type of Device
HEATING PAD
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd.
stamford CT 06902
MDR Report Key10431335
MDR Text Key204573011
Report Number1222304-2020-00009
Device Sequence Number1
Product Code IRT
UDI-Device Identifier74108355560
UDI-Public74108355560
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberHP01XF
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
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