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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 WW78
Device Problems Component Falling (1105); Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017)
Patient Problem Laceration(s) (1946)
Event Date 09/17/2016
Event Type  Injury  
Manufacturer Narrative
On 10/17/2016 - we have requested the device be returned to the manufacturer. To date, we have not received the device.
 
Event Description
On 10/17/2016 - the consumers granddaughter allegedly dropped a bottle on the product which cause the glass to shatter. The consumers granddaughter received cuts on leg. No medical attention was required.
 
Manufacturer Narrative
On 10/17/2016, we have requested the device be returned to the manufacturer. To date, we have not received the device. On (b)(6) 2017 added the upc code to the supplemental emdr. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2016, the consumers granddaughter allegedly dropped a bottle on the product which cause the glass to shatter. The consumers granddaughter received cuts on leg. No medical attention was required.
 
Manufacturer Narrative
On 10/17/2016 - we have requested the device be returned to the manufacturer. To date, we have not received the device. On 1/31/2017 - added the upc code to the supplemental emdr. On 2/15/2017 - manufacturers narrative: the product was received in the condition that deems impossible to perform testing due to the shattered glass. This occurence rarely happens with this product.
 
Event Description
(b)(6) 2016 - the consumer's grand daughter allegedly dropped a bottle on the product which cause the glass to shatter. The consumer's grand daughter received cuts on leg. No medical attention was required.
 
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Brand NameCONAIR
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 Key6033147
MDR Text Key57585669
Report Number1222304-2016-00041
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,Followup
Report Date 09/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW78
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 10/17/2016 Patient Sequence Number: 1
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