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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE CHPV

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INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE CHPV Back to Search Results
Model Number 82-3834
Device Problem Device Difficult to Program or Calibrate (1496)
Patient Problem Failure of Implant (1924)
Event Date 12/02/2021
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 facility reported the physician was not able to reprogram a hakim valve. They also tried to reprogram the valve using two different programmers unsuccessfully. Valve malfunction was suspected and it was explanted and replaced.
 
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 facility reported the physician was not able to reprogram a hakim valve. They also tried to reprogram the valve using two different programmers unsuccessfully. Valve malfunction was suspected and it was explanted and replaced.
 
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Brand NamePROG VALVE INLINE
Type of DeviceCHPV
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA
Manufacturer (Section G)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
mansfield MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key12964936
MDR Text Key285235055
Report Number3013886523-2021-00553
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K053107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number82-3834
Device Catalogue Number823834
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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