inforMED
MalfunctionFCE

OSCO COMBINATION

Received Feb 5, 1999 · Event occurred Dec 12, 1998

Report 1520456-1999-00001 · MDR key 209346

Device

Generic name

Enema Kit

Model number

NA

Catalog number

6775

Lot number

UNK

Product problems

  • Detachment Of Device Component
  • Entrapment of Device
  • Tip breakage

Patient

UNKNOWN

  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

REPORT RECEIVED FROM AMERICAN STORES CO WHICH STATES "TIP OF ENEMA PIPE BROKE OFF WHEN CONSUMER WAS USING AND LODGED ITSELF INTERNALLY. CONSUMER SOUGHT MEDICAL ATTENTION FOR THIS." NO FURTHER INFO IS AVAILABLE.

Remedial action

  • Other