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

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE CHPV

  • 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
 

INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE CHPV Back to Search Results
Catalog Number 823100
Device Problem Obstruction of Flow (2423)
Patient Problem Obstruction/Occlusion (2422)
Event Date 12/07/2020
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
A physician reported that the hakim programmable valve was obstructed. The valve was implanted to the patient via v-p shunt a few years ago (detail unknown) with unknown setting. On an unknown date, valve obstruction was observed with unknown patient's symptoms. Therefore, the valve was replaced to a new one on (b)(6) 2020. The patient was discharged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHAKIM PROGRAMMABLE VALVE
Type of DeviceCHPV
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08540
6099362319
MDR Report Key11097500
MDR Text Key224524055
Report Number3013886523-2020-00290
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,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number823100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-