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BARRIER EXTRA PROTECTION PLUS GOWN, LARGE

Received May 21, 2003 · Event occurred Apr 20, 2003

Report 2523357-2003-00001 · MDR key 461785

Device

Generic name

Gown, Surgical

Model number

NA

Catalog number

0540

Lot number

UNK

Product problems

  • Device Maintenance Issue

Patient

UNKNOWN

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

INITIAL REPORT FROM TERRITORY SALES MANAGER, CONCERNING ON ACCOUNT THAT HAD JUST CONVERTED FROM USING AN ENTIRE FLUID IMPERVIOUS GOWN TO A FLUID ZONED IMPERVIOUS GOWN. THIS REPORT IS FILED FOR NO. 1 ABOVE; COMPANY REPRESENTATIVE (SALES MANAGER) VISITED THE HOSPITAL AND WAS UNABLE TO GATHER ADDITIONAL INFO FOR THIS REPORT. NO BLOODBORNE PATHOGEN EXPOSURE WAS REPORTED.

Remedial action

  • Other