inforMED
MalfunctionFAX

FILIFORM

Received Jan 24, 2003

Report 2429473-2003-00005 · MDR key 440131

Device

Generic name

Urological

Manufacturer

Rusch Inc.

Model number

NA

Catalog number

342704

Lot number

UNK

Product problems

  • Detachment Of Device Component
  • Device, or device fragments remain in patient
  • Material Separation

Patient

UNKNOWN

  • No Consequences Or Impact To Patient
  • Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

CUSTOMER REPORTS CONNECTION CAME APART LEAVING FILIFORM INSIDE OF PATIENT.