DURASEAL 5ML 1 KIT/BOX FOR JAPAN JDSD5001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-21 for DURASEAL 5ML 1 KIT/BOX FOR JAPAN JDSD5001 manufactured by Integra Lifesciences Corporation.

Event Text Entries

[117834902] The device will not be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg report number: 3003418325-2018-00034.
Patient Sequence No: 1, Text Type: N, H10


[117834903] This is 1 of 2 reports. It was reported that on (b)(6) 2018, a jdsd5001 duraseal 5ml 1 kit/box for (b)(6) was used on a sta-mca anastomosis. The surgery was finished without any problems but the patient had fever on the first day, postoperatively. The cause of fever was said to be unknown. However, there was no doubt of infection according to the test values. During surgery, duraseal was sprayed after the dural closure. The open area of the skull was about 5-6 cm in diameter. Duraseal usage was 1. 5cc - 2. 5cc. According to the surgeon, it was not likely that duraseal contacted with the cerebrum directly as the patient had dural defect and surgicel was used to close the defect part. Additional information received was on 01aug2018 re-stating that there was no possibility that duraseal was applied to the brain directly since it was applied after the dura closure. The patient was a (b)(6) male.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003418325-2018-00033
MDR Report Key7802985
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-08-21
Date of Report2018-07-27
Date of Event2018-07-24
Date Mfgr Received2018-08-31
Date Added to Maude2018-08-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER KIMBERLY SHELLY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA LIFESCIENCES CORPORATION
Manufacturer Street105 MORGAN LANE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal Code08536
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURASEAL 5ML 1 KIT/BOX FOR JAPAN
Generic NameDURASEAL CRANIAL
Product CodeNQR
Date Received2018-08-21
Catalog NumberJDSD5001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION
Manufacturer Address105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-21

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