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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 W CATH ACC CERTAS PLUS SMALL & RA W/SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV W CATH ACC CERTAS PLUS SMALL & RA W/SG Back to Search Results
Catalog Number 828815
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Confusion/ Disorientation (2553)
Event Date 02/23/2022
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 in a (b)(6) female patient via v-p shunt on (b)(6), 2022 with setting 3. Disorientation did not improve. The set pressure was changed to setting 2, but the disorientation did not improve on (b)(6). The set pressure was changed to setting 1, but the disorientation did not improve on (b)(6). The valve was removed and replaced on (b)(6), 2022 and the patient recovered.
 
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Brand NameCRTS SM IL SG VLV W CATH ACC
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 Key13791622
MDR Text Key289961594
Report Number3013886523-2022-00092
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K182265
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 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828815
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2022
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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