MAUDE Adverse Event Report: CONAIR CORPORATION BMI SCALE; WEIGHT WATCHERS BMI SCALE

Model Number WW400GD

Device Problem Material Disintegration (1177)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016 - the consumer has agreed to accept a replacement device rather mailing the device for manufacturers investigation.Therefore, an investigation for the product is not necessary.The replacement device was sent to the consumer on march 21st, 2016.Consumer request replacement product.

Event Description

On (b)(6) 2016: the consumer alleged that the glass shattered on the product while standing on it.The consumer was not injured during the incident.

• Brand Name: BMI SCALE
• Type of Device: WEIGHT WATCHERS BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT
• MDR Report Key: 5531492
• MDR Text Key: 41656740
• Report Number: 1222304-2016-00019
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW400GD
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR