MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; BMI SCALE

Model Number WW708F

Device Problem Break (1069)

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

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2021 - the consumer accepted a replacement and will not send the product to the manufacturer.Therefore an investigation will not take place.

Event Description

On (b)(6) 2021 - the consumer claims that the product shattered while in use of the product.The consumer has returned the product.This product was under warranty and the consumer accepted a replacement.Therefore an investigation will not occur.

• Brand Name: CONAIR CORPORATION
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, 06902
• MDR Report Key: 11206940
• MDR Text Key: 229104810
• Report Number: 1222304-2021-00001
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108387257
• UDI-Public: 74108387257
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW708F
• 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 Outcome(s): Other
• Patient Age: 40 YR