MalfunctionKGO

NOVAPLUS

Received Jan 13, 2025 · Event occurred Dec 20, 2024

Report 21136983 · MDR key 21136983

Device

Generic name

Surgeons Gloves

Manufacturer

Ansell Healthcare Products Llc

Model number

V20685770

Catalog number

V20685770

Lot number

V20685770, MEDS00017A2

Patient

NA · Prefer Not To Disclose

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

Narrative

Description of Event or Problem

BLACK SPECK FOUND ON INSIDE OF SIZE 7 GLOVES. GLOVES AND PAPER SEQUESTERED BY PEDSP/PEDPIC DESK. FOUND BY [REDACTED NAME]. MANUFACTURER RESPONSE FOR SIZE 7 GLOVES, SIZE 7 GLOVES (PER SITE REPORTER), SAMPLE COLLECTED AND [REDACTED NAME] EMAILED.