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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES MANSFIELD PROG VALVE MICRO CHPV Back to Search Results
Catalog Number 823112
Device Problem Device Difficult to Program or Calibrate (1496)
Patient Problem Failure of Implant (1924)
Event Date 07/04/2021
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 hakim valve could not be adjusted and it was explanted on (b)(6) 2021. The valve was implanted at the beginning of 2020.
 
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Brand NamePROG VALVE MICRO
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 Key12216562
MDR Text Key263088056
Report Number3013886523-2021-00317
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2018
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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