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. |