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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 WW59GD
Device Problem Material Fragmentation (1261)
Patient Problem Injury (2348)
Event Date 06/22/2016
Event Type  Injury  
Manufacturer Narrative
On 7/12/2016 - we have requested the product to be returned to the manufacturer. To date, we have not received the product.
 
Event Description
On 7/12/2016 - the consumer alleges the product shattered while in use. The consumer claims to have cut her foot.
 
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Brand NameCONAIR
Type of DeviceBMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford CT 06902
Manufacturer Contact
1 cummings point rd.
stamford, CT 06902
MDR Report Key5818755
MDR Text Key50311002
Report Number1222304-2016-00031
Device Sequence Number1
Product Code MNW
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
Type of Report Initial
Report Date 07/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW59GD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/25/2016 Patient Sequence Number: 1
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