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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 WW52Y
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 09/24/2018
Event Type  malfunction  
Manufacturer Narrative
On 10/30/2018 - the consumer will be receiving a replacement, therefore the manufacturer will not be receiving the device for an investigation.
 
Event Description
On (b)(4) 2018 - per the consumer, the product shattered. The consumer is going to provide the serial number for a replacement.
 
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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 Key8019065
MDR Text Key125612608
Report Number1222304-2018-00023
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 10/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW52Y
Was Device Available for Evaluation? No
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 Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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