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

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

  • 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
 

CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3100
Device Problem Device Difficult to Program or Calibrate (1496)
Patient Problem Failure of Implant (1924)
Event Date 11/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the ous account manager, after a year and a half, a hakim programmable valve could not be programmed and was revised. It was replaced with another hakim valve. It will be returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8160143
MDR Text Key130215045
Report Number1226348-2018-10882
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-3100
Device Lot Number155414
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
-
-