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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG Back to Search Results
Catalog Number 828814PL
Device Problem Infusion or Flow Problem (2964)
Patient Problem Failure of Implant (1924)
Event Date 07/02/2021
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported a certas valve was implanted on (b)(6) 2021 with setting 3. After implantation, the valve was functioning properly. The patient returned the next day because the valve was malfunctioning (not draining). Csf was clear, so no apparent obstruction was observed. The valve was removed and replaced.
 
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Brand NameCRTS SM IL SG VLV ONLY
Type of DeviceCERTAS PLUS SMALL & RA 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 Key12217159
MDR Text Key263121592
Report Number3013886523-2021-00318
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828814PL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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