inforMED
MalfunctionFMC

BIOGEL SURGEONS GLOVE

Received Dec 11, 2017 · Event occurred Dec 4, 2017

Report 7103853 · MDR key 7103853

Device

Generic name

Surgeon's Gloves

Model number

30470

Catalog number

30470

Lot number

17G621

Product problems

  • Device Contamination with Chemical or Other Material

Patient

29 YR

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

Narrative

Description of Event or Problem

LATEX BIOGEL GLOVES WERE OPENED ONTO THE STERILE FIELD IN THE APPROPRIATE STERILE FASHION, WHEN THE GLOVES WERE OPENED BY THE SURGEON, A HAIR WAS NOTICED TO BE INSIDED OF THE GLOVE. THE GLOVES WERE IMMEDIATELY PASSED OFF THE FIELD AND REPLACED.