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

Model Number WW78

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 03/10/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 - we have received the device on (b)(6) 2019.The investigation has been complete.Below is the manufacturers narrative: manufacturers narrative: testing was not required.Performance was not an issue.Rolled steel has internal stresses that make it difficult to attach.Extra processes are in place, flattening of the steel, heat treating and a strong glue is used.With these steps in place, almost 100% of problems are eliminated.We have not seen this problem before and will be sure to advise production to be aware and check during the inspections.

Event Description

On (b)(6) 2019 - the consumer claims the metal strips on the product popped up and cut his sons finger.Medical attention was not received.

• 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: 8621061
• MDR Text Key: 145639547
• Report Number: 1222304-2019-00013
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108199256
• UDI-Public: 74108199256
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW78
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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