inforMED
MalfunctionFMP

STERILE PATIENT PROTECTIVE PAD COBAN

Received Sep 27, 2019 · Event occurred Sep 23, 2019

Report MW5090091 · MDR key 9134599

Device

Generic name

Protector, Skin Pressure

Catalog number

803-GP-10

Lot number

I19192001

Product problems

  • Device Contaminated During Manufacture or Shipping

Patient

82 YR

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

Narrative

Description of Event or Problem

A DEAD BUG WAS FOUND AS THE SURGEON WAS UNWRAPPING COBAN AROUND PT'S LEG. THE BUG WAS SMASHED BETWEEN LAYERS OF THE COBAN AND WAS DISCOVERED DURING THE UNWRAPPING OF THE COBAN WHILE DRAPING THE ASLEEP PT. THE PT HAD TO BE UN-DRAPED. NEW DRAPING SUPPLIES HAD TO BE RETRIEVED AND THE PT HAD TO BE RE-DRAPED WITH NEW STERILE SUPPLIES. FDA SAFETY REPORT ID# (B)(4).