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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR BMI SCALES

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CONAIR CORPORATION CONAIR BMI SCALES Back to Search Results
Model Number WW65
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2019
Event Type  malfunction  
Manufacturer Narrative
10/3/2019 - the consumer accepted a replacement product and will not be returned the product to the manufacturer. Therefore, an investigation will not take place.
 
Event Description
9/10/2019 - the consumer claims that the glass on the product shattered. Injuries did not occur. The consumer accepted a replacement.
 
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Brand NameCONAIR
Type of DeviceBMI SCALES
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford 06902
Manufacturer Contact
1 cummings point rd.
stamford, 
MDR Report Key9150528
MDR Text Key166954186
Report Number1222304-2019-00024
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 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberWW65
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

Patient Treatment Data
Date Received: 10/03/2019 Patient Sequence Number: 1
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