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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR BIA SCALE

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CONAIR CORPORATION CONAIR BIA SCALE Back to Search Results
Model Number WW65Y
Device Problems Material Fragmentation (1261); Explosion (4006)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2018
Event Type  malfunction  
Manufacturer Narrative
On 11/13/2018 - the device was not returned to the manufacturer. Therefore an investigation will not be complete.
 
Event Description
On 10/16/2018 - the consumer claims that the product exploded an hour after being used. Shards of glass were everywhere.
 
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Brand NameCONAIR
Type of DeviceBIA SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford 06902
Manufacturer Contact
1 cummings point rd.
stamford, 
MDR Report Key8063914
MDR Text Key127214509
Report Number1222304-2018-00024
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 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberWW65Y
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
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/13/2018 Patient Sequence Number: 1
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