MAUDE Adverse Event Report: AVID MEDICAL, INC. AVID TRUCUSTOM; GENERAL SURGERY TRAY

Catalog Number CHWE011-01

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2020

Event Type  malfunction  

Event Description

Hole in the wrap over the basin set of avid trucustom.Sterility concern.

• Brand Name: AVID TRUCUSTOM
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont dr; stonehouse commerce park; toano VA 23168
• MDR Report Key: 10641279
• MDR Text Key: 210203289
• Report Number: 10641279
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CHWE011-01
• Device Lot Number: 1381614
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1