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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA EXTERNAL DRAINAGE SET WITH TC/SA 30CM EXTERNAL DRAINAGE SYSTEMS

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INTEGRA NEUROSCICENCS IMPLANTS SA EXTERNAL DRAINAGE SET WITH TC/SA 30CM EXTERNAL DRAINAGE SYSTEMS Back to Search Results
Catalog Number 9ME623
Device Problem Defective Component (2292)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 10/10/2018
Event Type  Injury  
Manufacturer Narrative
The device was not yet 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.
 
Event Description
The distributor reported on behalf of the customer that the 9me623 external drainage set with tc/sa 30cm had an issue with the rigid tubing which lead to cerebrospinal fluid (csf) leakage on (b)(6) 2018. Complementary information received on 12nov2018 that the issue was detected when they were using the device. The event lead to an increase in surgery time of a few minutes. Another device of the same type was used.
 
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Brand NameEXTERNAL DRAINAGE SET WITH TC/SA 30CM
Type of DeviceEXTERNAL DRAINAGE SYSTEMS
Manufacturer (Section D)
INTEGRA NEUROSCICENCS IMPLANTS SA
2905 route des dolines
2905 route des dolines
sophia antipolis F-069 21
FR F-06921
Manufacturer (Section G)
INTEGRA NEUROSCICENCS IMPLANTS SA
2905 route des dolines
sophia antipolis F-069 21
FR F-06921
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8110421
MDR Text Key128586721
Report Number9612007-2018-00035
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number9ME623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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