FDA Adverse Event Injury Summary report: N

REMUNITY

MDR report key: 19692321 · Received July 5, 2024

Report

Report Number
MW5157095
Event Type
Injury
Date Received
July 5, 2024
Report Date
July 1, 2024
Manufacturer
UNK
Product Code
QJY
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PER COMMUNICATION FROM RN (B)(6) AT THE MD OFFICE: "PT OF DR. (B)(6) FROM (B)(6) ADMITTED TO (B)(6) FOR INFECTED ABDOMINAL SQ REMODULIN SITE. WE REDUCED HER REMODULIN TO 50NG/KG/MIN. DR. (B)(6) WILL HAVE TO DECIDE IF HE WANTS HER TO UPTITRATE." ONSET DATE OF SITE INFECTION IS UNKNOWN. DATE OF ADMITTANCE OR CURRENT LENGTH OF HOSPITALIZATION IS UNKNOWN. NO FURTHER INFO, DETAILS OR DATES AVAILABLE. SQ REMUNITY SELF-FILL PT. PT STARTED USING REMUNITY DEVICE ON (B)(6) 2023. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1459414 REMUNITY INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY UNK

Patients

Seq Age Sex Outcome Treatment
1 NA Female Hospitalization SILDENAFIL CITRATE.