MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURAGEN; DURA SUBSTITUTE

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

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

Event Date 04/15/2020

Event Type  malfunction  

Event Description

Duragen regeneration matrix product was not put on the sterile field correctly.Despite labeling with "stop" language, staff understood that the 2nd interior product was not sterile, but did read the smaller message after the "stop" message.Perhaps the written instructions should more clearly lead to how to properly handle the product.

• Brand Name: DURAGEN
• Type of Device: DURA SUBSTITUTE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 10453737
• MDR Text Key: 204377844
• Report Number: 10453737
• Device Sequence Number: 1
• Product Code: GXQ
• 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: 08/11/2020,07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Date Report to Manufacturer: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA