MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR SCALE; BMI SCALE

Device Problem Burst Container or Vessel (1074)

Patient Problem Injury (2348)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016: - the consumer has discarded the device.Therefore, an evaluation will not be possible.Consumer has requested a replacement.A replacement will be sent to the consumer once photos of purchase has been received.

Event Description

On (b)(6) 2016 - consumer alleges the glass on the scale exploded when placed on the floor.The consumer received cuts on hands and feet.The scale was discarded.Consumer will submit photos as proof of purchase.The consumer has requested a replacement.

• Brand Name: CONAIR SCALE
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• MDR Report Key: 5463925
• MDR Text Key: 39158888
• Report Number: 1222304-2016-00015
• Device Sequence Number: 0
• Product Code: MNW
• 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: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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: 30 YR