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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG Back to Search Results
Catalog Number NS9008
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Date 09/02/2021
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
A physician reported a hakim valve was implanted in a patient via lumbar peritoneal shunt on (b)(6) 2013 with unknown setting. The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). A shunt contrast was performed and the valve was obstructed. A leakage was also confirmed in three places on the catheter. The shunt reconstruction was performed on on (b)(6) 2021. During the removal the lumbar catheter ruptured and remains in the patient's body. No further information was provided by the hospital.
 
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Brand NameSPECIAL DEVICE UNITIZED PROGRA
Type of DeviceCHPV WITH 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 Key12512830
MDR Text Key272697647
Report Number3013886523-2021-00399
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 NumberNS9008
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 Received09/02/2021
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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