MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH AND NEPHEW CONSOLES; SAW, POWERED, AND ACCESSORIES

Catalog Number SN AAL7722006M/AAL113927

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Given to biomed.

• Brand Name: SMITH AND NEPHEW CONSOLES
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 14929376
• MDR Text Key: 295345932
• Report Number: 14929376
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2022,05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SN AAL7722006M/AAL113927
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2022
• Date Report to Manufacturer: 07/06/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Male