MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR BMI SCALE

Model Number TH300

Device Problems Burst Container or Vessel (1074); Extrusion (2934)

Patient Problem Injury (2348)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 - we have requested that the product be returned for evaluation.To date, we have not received the product.

Event Description

On (b)(6) 2016: the consumer alleges that the glass on the product exploded and cut her feet.

• Brand Name: CONAIR BMI SCALE
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd; stamford, CT 06902
• MDR Report Key: 5510854
• MDR Text Key: 40703896
• Report Number: 1222304-2016-00018
• Device Sequence Number: 1
• Product Code: MNW
• 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: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TH300
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2009
• 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: 35 YR