inforMED
MalfunctionNZP

INTEGUSEAL

Received Mar 22, 2016 · Event occurred Oct 31, 2015

Report 5517531 · MDR key 5517531

Device

Generic name

Sealant, Microbial

Lot number

P00203417

Product problems

  • Device Packaging Compromised
  • Moisture or Humidity Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

BEFORE OPENING THE PACKAGE OF INTEGUSEAL, IT WAS NOTICED THE DEVICE WAS ALREADY ACTIVATED DUE TO THE LIQUID IN THE PACKAGE. NO PATIENTS WERE AFFECTED. A NEW PACKAGE WAS USED FROM THE SAME LOT NUMBER AND WAS FINE.