Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. CODMAN VPV SYSTEM; VALVE PROGRAMMER
  • 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. CODMAN VPV SYSTEM; VALVE PROGRAMMER Back to Search Results
Catalog Number 82-3192R
Device Problem Device Difficult to Program or Calibrate (1496)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Attempts are being made to obtain additional information.Upon receipt of additional relevant information, a follow-up report will be submitted.
 
Event Description
As reported by the sales rep,during a procedure to program a valve, a vpv programmer displayed a yellow light and would not program.Another programmer was used to complete the procedure with a delay of one hour reported.
 
Manufacturer Narrative
Udi: (b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CODMAN VPV SYSTEM
Type of Device
VALVE PROGRAMMER
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key8189003
MDR Text Key131335136
Report Number1226348-2018-10899
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K061876
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number82-3192R
Was Device Available for Evaluation? No
Date Manufacturer Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-