MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURASEAL; SEALANT, DURAL

Model Number 202050

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  malfunction  

Event Description

From staff: it was reported that this duraseal mixture was not correct and as a result would not mix correctly.Staff in the room replaced duraseal with another from stock and there was no delay or harm to patient.Duraseal disposed of.

• Brand Name: DURASEAL
• Type of Device: SEALANT, DURAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus road; princeton NJ 08540
• MDR Report Key: 17341621
• MDR Text Key: 319198744
• Report Number: 17341621
• Device Sequence Number: 1
• Product Code: NQR
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 202050
• Device Catalogue Number: 202050
• Device Lot Number: 60375608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Weight: 88 KG