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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 WW-400
Device Problems Material Fragmentation (1261); Device Operates Differently Than Expected (2913); Physical Property Issue (3008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2016
Event Type  malfunction  
Manufacturer Narrative
On 1/4/2017 - we have requested the device be returned to the manufacturer. To date, we have not received the device.
 
Event Description
On 1/3/2017 - the consumer claims to have stood on the product. The glass on the product has shattered. No injuries occured.
 
Manufacturer Narrative
On 1/4/2016 we have requested the device be returned to the manufacturer. To date, we have not received the device. On 2/15/2016 - manufacturers narrative: the product was received in a condition that deems impossible to perform testing due to the shattered glass. This occurence rarely happens with this product.
 
Event Description
On (b)(6) 2017 - the consumer claims to have stood on the product. The glass on the product has shattered. No injuries occured.
 
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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 Key6232461
MDR Text Key64553482
Report Number1222304-2017-00001
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,Followup
Report Date 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW-400
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 01/09/2017 Patient Sequence Number: 1
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