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

Model Number WW912XF

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020 - the consumer did not provide their name or address information.Therefore we are unable to request the product to be returned to the manufacturer for an investigation.

Event Description

On (b)(6) 2020 - the consumer claims the product shattered when tapped against the toilet.Injuries did not occur.The consumer did not provide a name or address details.

• Brand Name: CONAIR CORPORATION
• Type of Device: BIA SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings poit rd.; stamford,
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 10482275
• MDR Text Key: 207727933
• Report Number: 1222304-2020-00012
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108356574
• UDI-Public: 74108356574
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW912XF
• 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