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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 Unspecified Infection (1930); Injury (2348)
Event Date 11/07/2020
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
2 of 3 reports. Other mfg report numbers: 3013886523-2020-00273, 3013886523-2020-00275. A physician reported the hakim peritoneal catheter was implanted and connected to a certas valve (product id:828804, lot#:4739012) and bactiseal (product id: 823073, lot#: 4397529) to the patient via v-p shunt on (b)(6) 2020 with an unknown setting. However, infection was observed at the peritoneal site and furthermore, csf flow to the peritoneal side could not be confirmed. Therefore, the valve was replaced to a new one on an unknown date. Type of infection/organism unknown. Treatment and or medication given for the infection is unknown.
 
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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 Key11074135
MDR Text Key223718244
Report Number3013886523-2020-00274
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828804
Device Lot Number4739012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2020
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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