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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG CHPV WITH SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG CHPV WITH SG Back to Search Results
Model Number 823162
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 03/02/2022
Event Type  Injury  
Event Description
A physician reported a hakim valve was implanted in a (b)(6) male patient via v-p shunt on (b)(6) 2021 with 80 mmh2o. The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). The patient was still ill after the valve was placed and the patient's condition did not change even when the setting was lowered to 60mmh2o. The valve was removed and replaced on (b)(6) 2022.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
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Brand NamePROG VALVE INLINE W SG
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 Key13871733
MDR Text Key289856899
Report Number3013886523-2022-00111
Device Sequence Number1
Product Code JXG
UDI-Device Identifier10381780519232
UDI-Public(01)10381780519232(17)250831(10)4959988
Combination Product (y/n)N
PMA/PMN Number
K041296
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 04/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number823162
Device Catalogue Number823162
Device Lot Number49599988
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2020
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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