inforMED
MalfunctionFOX

STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP

Received Aug 12, 2021 · Event occurred Jul 22, 2021

Report 3006260740-2021-03272 · MDR key 12315742

Device

Generic name

Stand, Infusion

Catalog number

PIC0220CE

Lot number

UNKNOWN

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

Description of Event or Problem

IT WAS REPORTED THE "CLICK" PART EASILY DETACHED FROM THE PATCH. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.