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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 TH300
Device Problems Burst Container or Vessel (1074); Extrusion (2934)
Patient Problem Injury (2348)
Event Date 01/27/2016
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2016 - we have requested that the product be returned for evaluation. To date, we have not received the product.
 
Event Description
On (b)(6) 2016: the consumer alleges that the glass on the product exploded and cut her feet.
 
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Brand NameCONAIR BMI SCALE
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 Key5510854
MDR Text Key40703896
Report Number1222304-2016-00018
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 03/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTH300
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
Date Device Manufactured01/01/2009
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: 03/18/2016 Patient Sequence Number: 1
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