MAUDE Adverse Event Report: A&E MEDICAL CORP. STERNALOCK CABLE FIXATION; CABLE, ELECTRODE

Model Number 94-1500-04-S

Patient Problem Insufficient Information (4580)

Event Date 08/09/2023

Event Type  malfunction  

• Brand Name: STERNALOCK CABLE FIXATION
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): A&E MEDICAL CORP.; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 17548019
• Report Number: 17548019
• Device Sequence Number: 1
• Product Code: IKD
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 94-1500-04-S
• Device Lot Number: 432535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Male