MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BIA SCALE

Model Number WW52Y

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 12/23/2018

Event Type  Injury  

Manufacturer Narrative

On 1/25/2018 - we have received the device on 1/23/2018 and the manufacturers inspection was complete.Below is the manufacturers narrative; manufacturers narrative 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.Sometimes the internal stress breaks the glass when no external event caused it.The number of events is very low and the technology so far has not provided a solution to prevent this on all glass scales.

Event Description

On (b)(6) 2018 - the consumer claims that the product shattered.While cleaning the consumer cut his finger.Medical attention was not received.

• Brand Name: CONAIR
• Type of Device: BIA SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 8277199
• MDR Text Key: 134086516
• Report Number: 1222304-2019-00001
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108230959
• UDI-Public: 74108230959
• Combination Product (y/n): N
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW52Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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