MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BIA SCALE

Model Number WW65Y

Device Problems Material Fragmentation (1261); Explosion (4006)

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

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

On 11/13/2018 - the device was not returned to the manufacturer.Therefore an investigation will not be complete.

Event Description

On 10/16/2018 - the consumer claims that the product exploded an hour after being used.Shards of glass were everywhere.

• 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: 8063914
• MDR Text Key: 127214509
• Report Number: 1222304-2018-00024
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 10074108294050
• UDI-Public: (01)10074108294050(10)1216JB(11)16110
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: WW65Y
• Was Device Available for Evaluation?: 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: 50 YR