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

Model Number WW711XF

Device Problem Explosion (4006)

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

Event Date 07/03/2020

Event Type  malfunction  

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 Description

7/6/2020: the consumer claims the product exploded.The consumer accepted a replacement.

• Brand Name: CONAIR CORPORATION
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford,
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 10388145
• MDR Text Key: 203299251
• Report Number: 1222304-2020-00008
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 00074108337290
• UDI-Public: 00074108337290
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: WW711XF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other