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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION BMI SCALE

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CONAIR CORPORATION CONAIR CORPORATION BMI SCALE Back to Search Results
Model Number WW707Y
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2020
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2020 - the device was returned to the manufacturer on 8/19/2020. An investigation is currently in progress.
 
Event Description
On (b)(6) 2020 - the consumer claims the product broke and glass was everywhere. The consumer had to step on the glass to get out of the bathroom. Medical attention was not required.
 
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Brand NameCONAIR CORPORATION
Type of DeviceBMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings poit rd.
stamford 06902
Manufacturer Contact
1 cummings point rd.
stamford 06902
MDR Report Key10431947
MDR Text Key204592882
Report Number1222304-2020-00010
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,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW707Y
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
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: 08/20/2020 Patient Sequence Number: 1
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