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

Model Number	WW711XF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
07/16/2020:the consumer accepted a product replacement.Therefore, the consumer will not be returned the product to the manufacturer for an investigation.
Event or Problem Description
7/6/2020: the consumer claims the product exploded.The consumer accepted a replacement.

• Brand Name: CONAIR CORPORATION
• Common Device Name: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford,
• MDR Report Key: 10388145
• Report Number: 1222304-2020-00008
• Device Sequence Number: 3026041
• Product Code: MNW
• UDI-Device Identifier: 00074108337290
• UDI-Public: 00074108337290
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: WW711XF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2020
• 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