FDA Adverse Event Malfunction Summary report: N

2PC VSYS/PRT/LOCKS 4NDL LW PFL

MDR report key: 971141 · Received December 26, 2007

Report

Report Number
1219930-2007-00880
Event Type
Malfunction
Date Received
December 26, 2007
Date of Event
November 12, 2007
Report Date
November 14, 2007
Manufacturer
NORTH HAVEN - USS
Product Code
LJT
PMA / PMN Number
K952748
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

SEX: UNK. PROCEDURE: UNK. ACCORDING TO THE REPORTER: THE CATHETER BROKE PRIOR TO BEING IMPLANTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 2PC VSYS/PRT/LOCKS 4NDL LW PFL NONE LJT NORTH HAVEN - USS UNK

Patients

Seq Age Sex Outcome Treatment
1 UNK YR