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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 WW707Y
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2018
Event Type  malfunction  
Manufacturer Narrative
On 7/6/2018 - the device was not returned to the manufacturer. The consumer also accepted a replacement. An investigation will not be taken place.
 
Event Description
On 7/6/2018 - the consumer claims that the product exploded. Details of any injuries was not provided.
 
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Brand NameCONAIR
Type of DeviceBMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford 06902
Manufacturer Contact
1 cummings point rd.
stamford, 
MDR Report Key7666802
MDR Text Key113637410
Report Number1222304-2018-00013
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 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2018
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?
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: 07/06/2018 Patient Sequence Number: 1
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