MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BIA SCALES

Model Number WW711

Device Problem Break (1069)

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

Event Date 11/04/2018

Event Type  malfunction  

Manufacturer Narrative

On 12/3/2018 - the consumer discarded the product and agreed to a replacement.An investigation will not be performed do to the product being discarded.

Event Description

On (b)(6) 2018 - the consumer claims that glass on the unit shattered.No injuries occurred and the consumer agree to a replacement.The consumer discarded the product, therefore an investigation will not be completed.

• Brand Name: CONAIR
• Type of Device: BIA SCALES
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 8126025
• MDR Text Key: 129333829
• Report Number: 1222304-2018-00027
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108337290
• UDI-Public: 74108337290
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2018
• 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