MalfunctionKGO

GAMMEX

Received Mar 15, 2023 · Event occurred Jan 25, 2023

Report 16544939 · MDR key 16544939

Device

Generic name

Surgeon's Gloves

Manufacturer

Ansell Healthcare Products Llc

Model number

20685765

Catalog number

20685765

Lot number

2207476904

Product problems

Flaked
Device Contaminated During Manufacture or Shipping

Patient

Unknown

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

Narrative

Description of Event or Problem

CHILDREN'S PHARMACY OVERNIGHT TECHNICIAN FOUND SOME FLAKES UPON OPENING ONE PAIR OF STERILE GLOVES, SIZE 6.5. THE STERILE GLOVES WERE SEQUESTERED, AND TECHNICIAN NOTIFIED PHARMACIST IN CHARGE. MANUFACTURER RESPONSE FOR GLOVES, STERILE GLOVES (PER SITE REPORTER) REPORTED TO REPS ON [REDACTED DATE] IN ORDER TO REQUEST MAILER.