MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BIA SCALE

Model Number WW707Y

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 the consumer has accepted a replacement product and will not be returning the device to manufacturer.Therefore an evaluation will not take place.

Event Description

On (b)(6) 2019 the consumer claims that the product shattered.No injuries occurred.The consumer has accepted a replacement.

• Brand Name: CONAIR
• Type of Device: BIA SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 8304579
• MDR Text Key: 137005988
• Report Number: 1222304-2019-00002
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108295156
• UDI-Public: 74108295156
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW707Y
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR