MAUDE Adverse Event Report: CONAIR CORPORATION BMI SCALE

Model Number WW585

Device Problem Burst Container or Vessel (1074)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) 2016 - we have requested the product be returned to the manufacturer for evaluation.To date, we have not received the device.Device not returned to manufacturer.

Event Description

(b)(6) 2016 - the consumer alleges that the product exploded into pieces of glass.The glass was embedded into the consumer's hand.It has not been determined if medical attention was received.

• Brand Name: 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: 5630937
• MDR Text Key: 44390558
• Report Number: 1222304-2016-00025
• Device Sequence Number: 1
• Product Code: MNW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/04/2016

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: WW585
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2016
• 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