MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; SCALE

Model Number WW705

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

On 8/16/2016 - per our risk management team, no injuries or property damaged occured.The consumer has agreed to receive a replacement product and discarded the original product.Therefore, an investigation is not necessary.Device not returned to manufacturer.

Event Description

On 7/12/2016 - the consumer claims that the glass on the product shattered while in use.No injuries occurred.

• Brand Name: CONAIR CORPORATION
• Type of Device: 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: 5879493
• MDR Text Key: 53052454
• Report Number: 1222304-2016-00032
• 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: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW705
• 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: 50 YR