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

Model Number WW701Y

Device Problem Material Disintegration (1177)

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

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 the consumer accepted a replacement device and has discarded the damaged product.Therefore an investigation will not be completed.

Event Description

On 7/8/2019 - the consumer claims that the products shattered into many pieces.No injuries occurred and the consumer accepted a replacement product.

• Brand Name: CONAIR CORPORATION
• 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: 8841075
• MDR Text Key: 194204976
• Report Number: 1222304-2019-00018
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108303677
• UDI-Public: 74108303677
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW701Y
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: 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