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

Model Number WW910F

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 - the consumer has requested a replacement device and will not send the device to the manufacturer.Therefore an investigation will not take place.

Event Description

On (b)(6) 2019 - the consumer claims that the glass on the product has shattered.The consumer has accepted a replacement.

• 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,
• MDR Report Key: 8577703
• MDR Text Key: 144169735
• Report Number: 1222304-2019-00012
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108349170
• UDI-Public: 74108349170
• Combination Product (y/n): N
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW910F
• Was Device Available for Evaluation?: No
• 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: 50 YR