inforMED
InjuryMRZ

CARTRIDGE RG MEDICATION 3ML

Received Aug 10, 2023

Report MW5122899 · MDR key 17508994

Device

Generic name

Accessories, Pump, Infusion

Patient

Female

  • Erythema
  • Pain
  • Swelling/ Edema
  • Erythema
  • Pain
  • Swelling/ Edema

Narrative

Description of Event or Problem

PT REPORTS THEIR INFUSION SITE IS VERY SWOLLEN, RED, AND PAINFUL WHEN THEY MOVE AROUND, WHICH IS OUT OF THE ORDINARY FOR THEM. PT IS REQUESTING LIDOCAINE/PRILOCAINE CREAM AND TRIAMCINOLONE CREAM; PT DOES NOT USE PLO-GEL. PT IS AGREE,ABLE TO POTENTIAL OUTREACH BY CNSS FOR EVALUATION. SQ SITE WAS PLACED (B)(6) 2023, PT ALSO REPORTS THE CARTRIDGES DISPENSED SPECIFICALLY FOR SQ TREPROSTINIL MS3 TEND TO BE LOOSE FITTING AND THEY HAVE WASTED MEDICATION ON AT LEAST 4 OCCURRENCES (DATE UNKNOWN). PT PROVIDED CARTRIDGE LOT NUMBER 220908, BUT CONFIRMED THIS ISSUE HAS OCCURRED WITH SEVERAL DIFFERENT DISPENSES. PT STATES THEY HAD EXISTING SUPPLY OF CARTRIDGES SPECIFIC TO REMODULIN DISPENSING THAT THEY USED TO CONTINUE SQ TREPROSTINIL INFUSION WITHOUT PROBLEMS. NO INTERRUPTION TO THERAPY OR ILL-EFFECTS REPORTED. UNKNOWN IF MD AWARE. NO FURTHER INFO, DETAILS OR DATES AVAILABLE. REF REPORTS: MW5122898, MW5122900, MW5122901. REPORTED TO (B)(6) BY PT/CAREGIVER.