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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 WW37GD
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2018
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2018 - the device was not returned to the manufacturer. Therefore, a investigation cannot be completed.
 
Event Description
On (b)(6) 2018 - per the consumer, the product shattered into glass shards. The consumer was not injured.
 
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Brand NameCONAIR
Type of DeviceBMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford 06902
Manufacturer Contact
1 cummings point rd.
stamford, 
MDR Report Key7641601
MDR Text Key112718912
Report Number1222304-2018-00011
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
Reporter Occupation
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW37GD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
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: 06/27/2018 Patient Sequence Number: 1
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