MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALES

Model Number WW701YF

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

01/19/2021 - the consumer had accepted a replacement product.Therefore, the product will not be available for an investigation.

Event Description

01/11/2021 - the consumer claims the product got hot and exploded.As a result, the consumer burnt her foot.The consumer has 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, CT
• MDR Report Key: 11206948
• MDR Text Key: 227923711
• Report Number: 1222304-2021-00002
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108303677
• UDI-Public: 74108303677
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW701YF
• 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: 50 YR