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

Catalog Number 202050

Device Problems Leak/Splash (1354); Patient-Device Incompatibility (2682)

Patient Problems Cerebrospinal Fluid Leakage (1772); Inflammation (1932); Organ Dehiscence (2502)

Event Date 01/28/2017

Event Type  Injury  

Event Description

The doctor stated that duraseal was used on three patients and all the patients got inflammation and dehiscence.All the patients are under 1 year old.Additional information has been requested.Linked to mfg.Report numbers: 3003418325-2017-00016, 3003418325-2017-00018.

Manufacturer Narrative

Additional information received: 11/06/2017: csf leakage post operative and surgical site infection were reported on a (b)(6) male patient.Date of incident: (b)(6) 2017.Revision/medical intervention was not required.Delay in surgery due to product problem was reported as greater than 10 days.

Manufacturer Narrative

Integra has performed a thorough review of the reported incident.There was no product received back (device used), and no lot number identified, as such a dhr review could not be performed.At the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.With the information provided a root cause could not be determined, as there is no way to reliably determine why the reported condition occurred.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7009750
• MDR Text Key: 91342194
• Report Number: 3003418325-2017-00017
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 MO