• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM HAKIM PROGRAMMABLE VALVE HAKIM VALVES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RAYNHAM HAKIM PROGRAMMABLE VALVE HAKIM VALVES Back to Search Results
Catalog Number XXX-HAKIM PROGRAMMABLE VALVE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 01/29/2019
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that after implantation of an unknown hakim programmable valve, the patient developed neurologic deficits related to intracranial hypertension. The valve settings were adjusted, and relief of symptoms was achieved. The patient was treated successfully after thorough assessment and careful choice of treatment approaches.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHAKIM PROGRAMMABLE VALVE
Type of DeviceHAKIM VALVES
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA 02767
Manufacturer Contact
kimberly shelly
325 paramount drive
raynham, MA 02767
MDR Report Key8484772
MDR Text Key140973386
Report Number1226348-2019-00048
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-HAKIM PROGRAMMABLE VALVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-