MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number WW52Y

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

On 10/30/2018 - the consumer will be receiving a replacement, therefore the manufacturer will not be receiving the device for an investigation.

Event Description

On (b)(4) 2018 - per the consumer, the product shattered.The consumer is going to provide the serial number for a replacement.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 8019065
• MDR Text Key: 125612608
• Report Number: 1222304-2018-00023
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108230959
• UDI-Public: 74108230959
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW52Y
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR