MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR BMI SCALE

Model Number WW707Y

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

On 7/6/2018 - the device was not returned to the manufacturer. The consumer also accepted a replacement. An investigation will not be taken place.

Event Description

On 7/6/2018 - the consumer claims that the product exploded. Details of any injuries was not provided.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 7666802
• MDR Text Key: 113637410
• Report Number: 1222304-2018-00013
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108295156
• UDI-Public: 74108295156
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: WW707Y
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 07/06/2018 Patient Sequence Number: 1