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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

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CONAIR CORPORATION CONAIR; BMI SCALE Back to Search Results
Model Number UNKNOWN
Device Problem Break (1069)
Patient Problem Laceration(s) (1946)
Event Date 10/23/2020
Event Type  Injury  
Manufacturer Narrative
On 11/12/2020 - we have requeted the device be returned to the manufacturer for an investigation.To date, we have not recieved the device.
 
Event Description
On 11/10/2020 - the consumer alleges that the product shattered in the bathroom.The consumer had a laceration as a result.
 
Manufacturer Narrative
11/12/2020: we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.4/27/2021: per the fda's request, submitted a supplemental mdr that does not include the age and dob.I also noticed the common device name and product code was incorrect.I made the change from a heating pad (irt) to a bmi scale (mnw).
 
Event Description
On (b)(6) 2020: the consumer alleges that the product shattered in the bathroom.The consumer had a laceration as a result.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
Type of Device
BMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd.
stamford CT 06902
MDR Report Key10828770
MDR Text Key215922824
Report Number1222304-2020-00024
Device Sequence Number1
Product Code MNW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/28/2021
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 No Information
Device Model NumberUNKNOWN
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/12/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
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