MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number WW701XF

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

09/22/"2022" - the consumer accepted a replacement.Therefore the device will not be returned to the manufacturer for an investigation.

Event Description

09/07/2021 - the consumer claims the product arrived shattered.The consumer accepted a replacement product.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• MDR Report Key: 12511851
• MDR Text Key: 282294964
• Report Number: 1222304-2021-00028
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108303677
• UDI-Public: 74108303677
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW701XF
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1