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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION BMI SCALE

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CONAIR CORPORATION BMI SCALE Back to Search Results
Model Number WW585
Device Problem Burst Container or Vessel (1074)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) 2016 - we have requested the product be returned to the manufacturer for evaluation. To date, we have not received the device. Device not returned to manufacturer.
 
Event Description
(b)(6) 2016 - the consumer alleges that the product exploded into pieces of glass. The glass was embedded into the consumer's hand. It has not been determined if medical attention was received.
 
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Brand NameBMI SCALE
Type of DeviceBMI SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford CT 06902
Manufacturer Contact
1 cummings point rd
stamford, CT 06902
MDR Report Key5630937
MDR Text Key44390558
Report Number1222304-2016-00025
Device Sequence Number1
Product Code MNW
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW585
Was Device Available for Evaluation? No Answer Provided
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
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/04/2016 Patient Sequence Number: 1
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