Description of Event or Problem · 0
PATIENT IS PREGNANT [MATERNAL EXPOSURE DURING PREGNANCY], TIRED [TIREDNESS], PAIN, REDNESS, AND SWELLING AT HER SITE; [SITE] RED, PAINFUL [INFUSION SITE PAIN], PAIN, REDNESS, AND SWELLING AT HER SITE; [SITE] RED, PAINFUL [INFUSION SITE REDNESS], PAIN, REDNESS, AND SWELLING AT HER SITE [INFUSION SITE SWELLING], NAUSEA [NAUSEA], HEADACHES [HEADACHE], ABDOMINAL SITE IS DUE TO CHANGE AS IT WAS FEELING HOT AND ITCHY [INFUSION SITE WARMTH], EXCESSIVE BLEEDING FROM SUBCUTANEOUS REMUNITY REMODULIN SITE; [SITE] HAS YELLOW AND WHITE DRAINAGE WITH BLOOD [INFUSION SITE BLEEDING], GROIN AND VAGINAL PAIN [GROIN PAIN], GROIN AND VAGINAL PAIN [VAGINAL PAIN] [SITE], RED, PAINFUL AND YELLOW AND WHITE DRAINAGE WITH BLOOD [INFUSION SITE DISCHARGE]. HER SITES ONLY LAST AROUND 2 WEEKS [DEVICE MAINTENANCE ISSUE]. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).