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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES HOLDING CORPORATION DURASEAL 5ML 1 KIT/BOX FOR JAPAN; DURASEAL CRANIAL
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INTEGRA LIFESCIENCES HOLDING CORPORATION DURASEAL 5ML 1 KIT/BOX FOR JAPAN; DURASEAL CRANIAL Back to Search Results
Catalog Number JDSD5001
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/25/2014
Event Type  malfunction  
Event Description
When the content of the product was sprayed on the patient during a craniotomy, the doctor confirmed "the gel would not be immobilized but the liquid material flew." after it was vacuumed for removal, the case was completed with no problem by using new one.Patient age and gender unknown.There was no patient harm.Operating time was extended less than 30 minutes.There was no tissue damage.There was no bleeding.Nothing fell into the cavity.
 
Manufacturer Narrative
To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.
 
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Brand Name
DURASEAL 5ML 1 KIT/BOX FOR JAPAN
Type of Device
DURASEAL CRANIAL
Manufacturer (Section D)
INTEGRA LIFESCIENCES HOLDING CORPORATION
plainsboro NJ 08536
Manufacturer Contact
rowena bunuan
315 enterprise dr.
plainsboro, NJ 08536
6099362393
MDR Report Key4307448
MDR Text Key5270469
Report Number3003418325-2014-00010
Device Sequence Number1
Product Code NQR
Combination Product (y/n)N
PMA/PMN Number
P040034
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 10/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberJDSD5001
Device Lot NumberN4B0624X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/31/2014
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 Initial
Patient Sequence Number1
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