inforMED
InjuryGBW

PERITONEAL REFLUX CONTROL CATHETER

Received Sep 25, 1998 · Event occurred Jul 7, 1998

Report 2132740-1998-00024 · MDR key 189032

Device

Generic name

Peritoneal Catheter

Model number

NL850-1390

Catalog number

NL850-1375

Lot number

UNK

Product problems

  • Component(s), broken
  • Explanted

Patient

15 YR

  • Surgical procedure

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A CATHETER WAS REMOVED FROM A PT DUE TO BREAKAGE OF THE VALVE TUBE THAT WAS CONFIRMED AT THE TIME OF REVISION/EXPLANT. THE PHYSICIAN REPORTED THAT HE THINKS THE BREAKAGE WAS CAUSED BY THE GROWTH OF THE PT, WHO BECAME FIFTEEN YEARS OLD AND TALLER WHEN THIS EVENT OCCURRED. THE PT, AS THE PHYSICIAN REPORTED, HAD LIVED NORMALLY WITHOUT ANY EXERCISE RESTRICTION SINCE THE INITIAL IMPLANTATION. THE PT LEFT THE HOSP AND IS LIVING NORMALLY WITH EXERCISE RESTRICTION.