MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number WW707

Device Problem Break (1069)

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

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018 - device not returned to manufacturer.

Event Description

On (b)(6) 2017 - the consumer claims that glass shattered on the product.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 7225382
• MDR Text Key: 98734852
• Report Number: 1222304-2017-00038
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 10074108295156
• UDI-Public: (01)10074108295156
• 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: 01/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW707
• Was the Report Sent to FDA?: 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: 40 YR