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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828804
Device Problem Infusion or Flow Problem (2964)
Patient Problems Ventricle, Abnormality Of (2078); Obstruction/Occlusion (2422)
Event Date 12/14/2020
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 facility reported that the certas inlin valve was implanted on (b)(6) 2020 to a patient via v-p shunt on unknown date with setting 5. However, on (b)(6) 2020, ventricular enlargement was observed under mri without any clinical symptoms. The physician suspected valve obstruction. Therefore, the valve will be replaced to a new one (828800) on (b)(6) 2020.
 
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Brand NameCERTAS INLIN VLV ONLY W/SPHNGD
Type of DeviceCERTAS PLUS W/ SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08540
6099362319
MDR Report Key11097556
MDR Text Key224522904
Report Number3013886523-2020-00292
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K143111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
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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