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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR SCALE BMI SCALE - WW41GD

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CONAIR CORPORATION CONAIR SCALE BMI SCALE - WW41GD Back to Search Results
Model Number WW401GD
Device Problem Expulsion (2933)
Patient Problem Laceration(s) (1946)
Event Date 01/21/2016
Event Type  Injury  
Manufacturer Narrative
On 2/9/2016 - the products has been returned for evaluation. Evaluation is currently in progress.
 
Event Description
On (b)(6) 2016 - the consumer alleges that the product exploded and cut the consumers finger.
 
Manufacturer Narrative
Feb. 09, 2016 - the product has been returned for evaluation. Evaluation is currently in progress. Mar. 07, 2016 - the product received is in the condition that deems impossible to perform testing due to the shattered glass. This occurence rarely happens with this product. Device is currently under investigation.
 
Event Description
On (b)(6) 2016 - the consumer alleges that the product exploded and cut the consumers finger.
 
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Brand NameCONAIR SCALE
Type of DeviceBMI SCALE - WW41GD
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford CT 06902
Manufacturer Contact
1 cummings point rd.
stamford, CT 06902
MDR Report Key5447734
MDR Text Key38586472
Report Number1222304-2016-00009
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 consumer
Type of Report Initial,Followup
Report Date 01/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW401GD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2016
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/19/2016 Patient Sequence Number: 1
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