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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828806
Device Problem Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Date 03/22/2022
Event Type  Injury  
Event Description
A physician reported a certas valve was implanted in a (b)(6) year-old male patient via v-p shunt in (b)(6) 2022 due to subarachnoid hemorrhage. Shunt failure was suspected, the valve was removed on (b)(6) 2022. Damage was found on the silicone housing of the valve after removal.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
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Brand NameCERTAS INLIN VLV SPHN/UNIT CAT
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 
6099362319
MDR Report Key14022264
MDR Text Key288674723
Report Number3013886523-2022-00142
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,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828806
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/03/2022
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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