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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION BMI SCALE WEIGHT WATCHERS BMI SCALE

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CONAIR CORPORATION BMI SCALE WEIGHT WATCHERS BMI SCALE Back to Search Results
Model Number WW400GD
Device Problem Material Disintegration (1177)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2016
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2016 - the consumer has agreed to accept a replacement device rather mailing the device for manufacturers investigation. Therefore, an investigation for the product is not necessary. The replacement device was sent to the consumer on march 21st, 2016. Consumer request replacement product.
 
Event Description
On (b)(6) 2016: the consumer alleged that the glass shattered on the product while standing on it. The consumer was not injured during the incident.
 
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Brand NameBMI SCALE
Type of DeviceWEIGHT WATCHERS BMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford CT 06902
Manufacturer Contact
1 cummings point rd.
stamford, CT 
MDR Report Key5531492
MDR Text Key41656740
Report Number1222304-2016-00019
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
Remedial Action Replace
Type of Report Initial
Report Date 03/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW400GD
Was Device Available for Evaluation? No Answer Provided
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 Unkown

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