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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 XXX-HAKIM PROGRAMMABLE VALVE
Device Problem No Device Output (1435)
Patient Problems Fatigue (1849); Headache (1880); Nausea (1970)
Event Date 03/18/2021
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 patient was experiencing nausea, headache and fatigue and it was impossible to adjust a hakim valve. The valve was implanted in 2004 and it was replaced with a new one.
 
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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 Key11636480
MDR Text Key244608520
Report Number3013886523-2021-00161
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-HAKIM PROGRAMMABLE VALVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Yes
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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