MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number WW67N

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2021 the consumer accepted a replacement and will not return the device to the manufacturer for an investigation.

Event Description

On (b)(6) 2021 the consumer claims the product shattered.The consumer discarded the product and accepted a replacement.

• 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: 13008835
• MDR Text Key: 284116957
• Report Number: 1222304-2021-00035
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108119940
• UDI-Public: 74108119940
• 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
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: WW67N
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1