MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR SCALE; BMI SCALE - WW41GD

Model Number WW401GD

Device Problem Expulsion (2933)

Patient Problem Laceration(s) (1946)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

On 2/9/2016 - the products has been returned for evaluation.Evaluation is currently in progress.

Event Description

On (b)(6) 2016 - the consumer alleges that the product exploded and cut the consumers finger.

Manufacturer Narrative

Feb.09, 2016 - the product has been returned for evaluation.Evaluation is currently in progress.Mar.07, 2016 - the product received is in the condition that deems impossible to perform testing due to the shattered glass.This occurence rarely happens with this product.Device is currently under investigation.

Event Description

On (b)(6) 2016 - the consumer alleges that the product exploded and cut the consumers finger.

• Brand Name: CONAIR SCALE
• Type of Device: BMI SCALE - WW41GD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 5447734
• MDR Text Key: 38586472
• Report Number: 1222304-2016-00009
• Device Sequence Number: 1
• Product Code: MNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW401GD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Was Device Evaluated by Manufacturer?: 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: 40 YR