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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 Infusion or Flow Problem (2964)
Patient Problems Swelling (2091); Injury (2348)
Event Date 08/19/2020
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 physician reported fluid retention on a patient with a certas valve: the valve was implanted via l-p shunt. On (b)(6) 2020 with unknown setting. The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj). About one month after surgery, as the patient's abdominal swelling did not subside, an x-ray was performed, and fluid retention was found at the route of the abdominal catheter. Therefore, the valve was replaced with a new one on (b)(6) 2020.
 
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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
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key10517852
MDR Text Key206501772
Report Number3013886523-2020-00097
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2020
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
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
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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