MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number WW78

Device Problem Break (1069)

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

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020: the consumer discarded the device and accepted a replacement.Therefore an investigation will not take place.

Event Description

On (b)(6) 2020 the consumer claims that the scale shattered during the middle of the night.Injuries did not occur.The consumer discarded the product and will accept a replacement.Therefore an investigation will not occur.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford,
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 9726960
• MDR Text Key: 198539050
• Report Number: 1222304-2020-00002
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108199256
• UDI-Public: 74108199256
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW78
• 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
• Patient Age: 50 YR