MAUDE Adverse Event Report: CONAIR LLC. CONAIR; BMI SCALE

Model Number WW78

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 - per the consumer, their child kicked the device and the glass shattered.Their child did not sustain any injuries.The consumer accepted a replacement.

Manufacturer Narrative

On (b)(6) 2022 - the consumer accepted a replacement device and will not be returning the product to the manufacturer.Therefore an investigation will not occur.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR LLC.; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.,; stamford, CT 06902
• MDR Report Key: 14407553
• MDR Text Key: 300230779
• Report Number: 1222304-2022-00019
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108199256
• UDI-Public: 74108199256
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WW78
• 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
• Patient Outcome(s): Other