MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL CRANIAL

Catalog Number 202050

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A customer reported that a patient had a cerebrospinal fluid (csf) leak after a 202050 duraseal dural sealant system had been used in a craniotomy procedure on (b)(6) 2020.Additional information has been requested.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h4, h6, h10.Duraseal was not returned for evaluation (as it was used in the procedure); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• MDR Report Key: 10603644
• MDR Text Key: 209140737
• Report Number: 3003418325-2020-00017
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: 60228887
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1