MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR SCALE; WW707 SCALE

Model Number WW707

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

On 2/9/2016 - risk management team has attempted to contact the consumer on three occasions to assist in this matter and retrieve the product for evaluation.To date, the consumer has not responded.Device not returned to manufacturer.

Event Description

Consumer alleges to have cut her thumb while cleaning the product.Consumer seeked medical attention for her injury.

• Brand Name: CONAIR SCALE
• Type of Device: WW707 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: 5457486
• MDR Text Key: 38960513
• Report Number: 1222304-2016-00014
• 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: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW707
• 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): Hospitalization
• Patient Age: 50 YR