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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 828814
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 09/08/2021
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
1 of 2 reports. Other mfg report number: 3013886523-2021-00403. A physician reported a certas plus valve (id 828814 ) and a bactiseal peritoneal catheter (id 823074) were implanted to a patient via ventricular peritoneal shunt on an unknown date with an unknown setting. The set pressure could not be changed and valve obstruction was suspected. The patient had a head injury that caused a fracture in the skull near the valve and there was also suspicion that the valve was damaged. The valve and catheter were removed and replaced on (b)(6) 2021.
 
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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 Key12512839
MDR Text Key272702248
Report Number3013886523-2021-00402
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 foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828814
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
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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