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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828805
Device Problem Infusion or Flow Problem (2964)
Patient Problems Headache (1880); Injury (2348)
Event Date 11/28/2020
Event Type  Injury  
Manufacturer Narrative
Unique device identifier (udi): (b)(4). The certas valve was not returned for evaluation (per customer, not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed. The cause(s) of the difficulty reported by the customer could not be determined. If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this and similar issues. At present, we consider this complaint to be closed.
 
Event Description
A physician reported that a certas valve flow was not confirmed at the peritoneal side. The valve was implanted in a (b)(6) year-old female via v-p shunt on (b)(6) 2020 with setting 4. On (b)(6) 2020, the patient complained of headache and the shunt contrast was performed. Then it was found that the flow to the peritoneal side was not confirmed and the contrast agent was retained around the valve. On (b)(6) 2020 the valve was replaced and during the replacement the siphon guard tore at the connection of the valve and siphon guard. The patient recovered.
 
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Brand NameCERTAS INLINE VLV W/ SPHNGRD
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 Key11074132
MDR Text Key223717659
Report Number3013886523-2020-00276
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
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 Number828805
Device Lot Number4469639
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
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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