CARTRIDGE RG MEDICATION 3ML
Received Aug 10, 2023
Report MW5122899 · MDR key 17508994
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Chengdu Shifeng Medical Technology Co., Lt.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.