MalfunctionKOA

MONARCH HSG TRAY PACK

Received Aug 11, 2023 · Event occurred Jul 17, 2023

Report 17509005 · MDR key 17509005

Device

Generic name

Surgical Instruments, G-u, Manual (and Accessories)

Manufacturer

Monarch Medical Products, Inc.

Model number

MM1157

Lot number

55924-2302

Patient

Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

MONARCH HSG TRAY ITEM# MM1157, LOT# 55924-2302, [REDACTED DATE] WAS UNBOXED AND UPON INSPECTION REVEALED THAT THE BETADINE INSIDE THIS STERILE PACK BURST AND COVERING THE CONTENTS OF THE CONTENTS WITHIN. MANUFACTURER RESPONSE FOR MONARCH HSG TRAY PACK, MONARCH HSG TRAY PACK (PER SITE REPORTER): ISSUE WAS REPORTED TO THE VENDOR AT 8:20AM ON [REDACTED DATE]. VENDOR ADVISED THAT THIS THE FIRST REPORT OF AN INCIDENT OF THIS TYPE, HE RECORDED THE PRODUCT#, LOT# AND EXPIRATION DATE FOR DOCUMENTATION PURPOSES AND IS SENDING A REPLACEMENT PRODUCT.