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

Model Number WW707Y

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020 - the device was returned to the manufacturer on 8/19/2020.An investigation is currently in progress.

Event Description

On (b)(6) 2020 - the consumer claims the product broke and glass was everywhere.The consumer had to step on the glass to get out of the bathroom.Medical attention was not required.

Manufacturer Narrative

10/6/2020 - we have received the device and completed the investigation.Below is the manufacturers narrative: manufacturers narrative: no testing possible, unit's glass was broken into small 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.

Event Description

7/24/2020 - the consumer claims the product broke and glass was everywhere.The consumer had to step on the glass to get out of the bathroom.Medical attention was not required.

• Brand Name: CONAIR CORPORATION
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings poit rd.; stamford 06902
• MDR Report Key: 10431947
• MDR Text Key: 204592882
• Report Number: 1222304-2020-00010
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108295156
• UDI-Public: 74108295156
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW707Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR