MalfunctionGDY

ALLCARE

Received Dec 27, 2024 · Event occurred Sep 27, 2024

Report 21025982 · MDR key 21025982

Device

Generic name

Gauze/sponge, Internal, X-ray Detectable

Manufacturer

Allcare, Inc

Model number

AL1818

Catalog number

AL1818

Lot number

21XC05

Patient

71 YR · Male

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

Narrative

Description of Event or Problem

HAIR FOUND IN STERILE LAP SPONGE PACK. MANUFACTURER RESPONSE FOR STERILE LAPAROTOMY SPONGE, (BRAND NOT PROVIDED) (PER SITE REPORTER). A NO CHARGE REPLACEMENT PROVIDED. REPORTED BUT NO RESPONSE.