InjuryKJT
AUTO SUTURE CHEMOSITE
Received Sep 12, 1996 · Event occurred Aug 2, 1996
Report 1219161-1996-00063 · MDR key 38452
Device
Generic name
Implantable Access System
Manufacturer
United States Surgical Corp.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Component(s), broken
Patient
UNKNOWN
- Failure of Implant
- Surgical procedure, repeated
Narrative
Description of Event or Problem
THE DEVICE WAS IMPLANTED AS AN ACCESS PORT. REPORTEDLY, SEVEN MONTHS AFTER IT WAS IMPLANTED A CRACK WAS NOTICED IN THE CATHETER. THE SURGEON IMPLANTED A NEW PORT SYSTEM. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.