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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM PROGRAMMABLE VALVE CHPV

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INTEGRA LIFESCIENCES MANSFIELD HAKIM PROGRAMMABLE VALVE CHPV Back to Search Results
Catalog Number 823100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure of Implant (1924)
Event Date 12/13/2021
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 a hakim valve was implanted and did not work. It was removed and the event led to 3 hours surgical delay.
 
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Brand NameHAKIM PROGRAMMABLE VALVE
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 Key13117033
MDR Text Key282956280
Report Number3013886523-2021-00572
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,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2020
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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