MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; SCALE

Model Number WW721

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

On 1/30/2017 - we have requested the device be returned to the manufacturer.To date, we have not received the device.Device not returned to manufacturer.

Event Description

On (b)(6) 2017 - the consumer claims that the glass on the product shattered after stepping on it.The consumer cut her finger.No medical attention was required.

Manufacturer Narrative

On (b)(6) 2017 - we have requested the device be returned to the manufacturer.To date, we have not received the device.On (b)(6) 2017 - the product was received in a condition that deems impossible to perform testing due to the shattered glass.This occurrence rarely happens with this product.

Event Description

On (b)(6) 2017 - the consumer claims that the glass on the product shattered after stepping on it.The consumer cut her finger.No medical attention was required.

• Brand Name: CONAIR
• 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: 6335519
• MDR Text Key: 67580180
• Report Number: 1222304-2017-00004
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108333025
• UDI-Public: 74108333025
• 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,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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: 40 YR