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

Model Number WW346X

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/03/2024

Event Type  Injury  

Manufacturer Narrative

1/29/2024: we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.

Event Description

On (b)(6) 2024: the consumer claims to have cut his foot from the device.Medical attention was not received.

• Brand Name: CONAIR
• Type of Device: BIA 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: 18594347
• MDR Text Key: 333900069
• Report Number: 1222304-2024-00001
• 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
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: WW346X
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2024
• 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