MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number WW37BFX

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020: the consumer claims the claims the glass shattered.Injuries did not occur.Consumer accepted a replacement.

Event Description

On (b)(6) 2020: the consumer claims the claims the glass shattered.Injuries did not occur.Consumer accepted a replacement.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings poit rd.; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford 06904
• MDR Report Key: 10574567
• MDR Text Key: 208977053
• Report Number: 1222304-2020-00018
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108259134
• UDI-Public: 74108259134
• 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

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: WW37BFX
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2020
• 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