inforMED
MalfunctionFAX

RUSCH

Received Jan 31, 2002

Report 2429473-2002-00020 · MDR key 375275

Device

Generic name

Spiral Filform

Manufacturer

Rusch, Inc.

Model number

NA

Catalog number

342706

Lot number

105872

Product problems

  • Detachment Of Device Component
  • Peeled/Delaminated

Patient

UNKNOWN

  • No Consequences Or Impact To Patient
  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE CUSTOMER REPORTS THAT THE SPIRAL FILFORM WAS STRIPPED INSIDE.