InjuryMED

ALCAVIS 50 SOLUTION-500ML #15501-12 B/CS

Received May 4, 2026 · Event occurred Apr 10, 2026

Report MW5187677 · MDR key 25085732

Device

Generic name

Sterilant, Medical Devices

Manufacturer

Angelini Pharma Inc.

Catalog number

23-1501-8

Lot number

0513

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE AS SHE WANTED CUSTOMER SERVICE TO SEND ALCAVIS ON TRAVEL, ADVISE IT WAS NOT POSSIBLE. THEN STATED THAT LAST TIME IN 5/10 (B)(4) WHEN SHE TRAVELED AND SHE CARRIED IT ON THE PLANE WITH HER, IT BROKE AND SHE GOT SICK. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).