MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number	WW78
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 - the product was not returned to the manufacturer.An evaluation cannot be complete.
Event or Problem Description
On (b)(6) 2018 - the consumer claims the product shattered while walking past in the bathroom.No injuries occued.

• Brand Name: CONAIR
• Common Device Name: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• MDR Report Key: 7629184
• Report Number: 1222304-2018-00009
• Device Sequence Number: 1424716
• Product Code: MNW
• UDI-Device Identifier: 00074108295156
• UDI-Public: 00074108295156
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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
• Operator of Device: No Information
• Device Model Number: WW78
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR