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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 Consequences Or Impact To Patient (2199)
Event Date 10/22/2017
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2017: we received the device from the consumer. The device is currently under investigation. On (b)(6) 2017 cause: internal stress during safety glass manufacturing. Condition has been investigated and described in earlier report. During the glass manufacturing process, a small percentage of product develops inherent stress. This causes the glass to break without notice or under normal use conditions. This is a technology issue that has yet to be resolved 100%. Our failure rate is very low, 1 scale in 10,000.
 
Event Description
On (b)(6) 2017 - the consumer claims that product shattered. No injuries occurred.
 
Manufacturer Narrative
On 11/14/2017 - we received the device from the consumer. The device is currently under investigation.
 
Event Description
On 10/30/2017 - the consumer claims that product shattered. No injuries occurred.
 
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Brand NameCONAIR CORPORATION
Type of DeviceBMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford 06902
Manufacturer Contact
1 cummings point rd.
stamford, CT 06902
MDR Report Key7046295
MDR Text Key251877760
Report Number1222304-2017-00036
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 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW707Y
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/20/2017 Patient Sequence Number: 1
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