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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 WW701Y
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2016
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2016 the device will not be returned for evaluation as the consumer has agreed to received a new product.Device not returned to manufacturer.
 
Event Description
On (b)(6) 2016 the consumer alleges that the glass on the product has shattered.No injuries have occurred.The consumer has agreed to accept another product.
 
Manufacturer Narrative
On 10/12/2016 - the device will not be returned for evaluation as the consumer has agreed to received a new product.On 2/7/2016 - supplemental emdr contains the udi.
 
Event Description
On 10/12/2016 - the consumer alleges that the glass on the product has shattered.No injuries have occurred.The consumer has agreed to accept another product.
 
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Brand Name
CONAIR
Type of Device
BMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford CT 06902
Manufacturer Contact
1 cummings point rd
stamford, CT 06902
MDR Report Key6033143
MDR Text Key57625847
Report Number1222304-2016-00040
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 Other
Type of Report Initial,Followup
Report Date 10/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberWW701Y
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/17/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/07/2017
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age35 YR
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