MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALES

Model Number WW65

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2019

Event Type  malfunction  

Manufacturer Narrative

10/3/2019 - the consumer accepted a replacement product and will not be returned the product to the manufacturer.Therefore, an investigation will not take place.

Event Description

9/10/2019 - the consumer claims that the glass on the product shattered.Injuries did not occur.The consumer accepted a replacement.

• Brand Name: CONAIR
• Type of Device: BMI SCALES
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 9150528
• MDR Text Key: 166954186
• Report Number: 1222304-2019-00024
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108294050
• UDI-Public: 74108294050
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: WW65
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2019
• 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: 40 YR