MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BIA SCALE

Model Number WW303Y

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2018 - we are waiting for the consumer to submit the product to the manufacturer for investigation.To date, we have not received the product.

Event Description

On (b)(6) /2018 - the consumer claims the unit has shattered in his hand and cut his finger while cleansing the product.Medical attention was not received.

Event Description

5/16/2018: the consumer claims the unit has shattered in his hand and cut his finger while cleanging the product.Medical attention was not received.

Manufacturer Narrative

5/16/2018: we are waiting for the consumer to submit the product to the manufacturer for investigation.To date, we have not received the product.6/28/2018: the product has been investigated by the manufacturer.Below is the manufactures narrative: no testing was possible.Glass scale had broken into many pieces.During the process to make the glass shard proof, or safety glass, there is an anomaly that is seen on very few finished glass parts.There is internal stress that is sometimes created during the heat process.This stress can not be determined through normal testing.During use at specific temperatures the stress becomes apparent though making contact by either stepping or banging the scale against something hard.The number of events is very low and the technology so far has not provided a solution to prevent this on all glass scales.6/28/2018: the supplement emdr also contains a correction in the consumers name.First name should be (b)(6).Not (b)(6).

• Brand Name: CONAIR
• Type of Device: BIA SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• MDR Report Key: 7518004
• MDR Text Key: 108373086
• Report Number: 1222304-2018-00007
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108297174
• UDI-Public: 74108297174
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW303Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR