MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BIA SCALE

Model Number WW702W

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018 the consumer has agreed to recieve a replacement and will not return the product.Therefore, an investigation cannot be complete.

Event Description

On (b)(6) 2018 the consumer claims that the product blew up.The consumer has accepted a replacement will not be returning the product to the manufacturer.

• 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: 8173413
• MDR Text Key: 130794774
• Report Number: 1222304-2018-00026
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 00074108367228
• UDI-Public: 00074108367228
• 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: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW702W
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 50 YR