MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES, INC. EP IMPLANT TRAY; TRAY, SURGICAL

Catalog Number ORHS070-12

Device Problem Component Missing (2306)

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

Event Date 09/04/2014

Event Type  malfunction  

Event Description

Pacing cables were missing out out implant pack.We used single sterile pacing cables for the procedure.

• Brand Name: EP IMPLANT TRAY
• Type of Device: TRAY, SURGICAL
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES, INC.; 25 heywood rd; arden NC 28704
• MDR Report Key: 4093764
• MDR Text Key: 4830160
• Report Number: 4093764
• Device Sequence Number: 1
• Product Code: FSM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: ORHS070-12
• Device Lot Number: 966252
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2014
• Date Report to Manufacturer: 09/16/2014
• Patient Sequence Number: 1
• Patient Age: 70 YR