MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

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.

• 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 Key: 6033147
• MDR Text Key: 57585669
• Report Number: 1222304-2016-00041
• Device Sequence Number: 1
• Product Code: MNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• 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 Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW78
• Is the Reporter a Health Professional?: No
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR