FDA Adverse Event
Injury
Summary report: N
PERITONEAL DIALYSIS
MDR report key: 17524389
·
Received August 12, 2023
Report
- Report Number
- MW5131336
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- April 12, 2022
- Manufacturer
- UNKNOWN
- Product Code
- FKX
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
ON (B)(6) 2022, IT WAS REPORTED A PATIENT WAS ON ANTIBIOTICS DUE TO PERITONITIS. THE CAUSE WAS REPORTED AS A HOLE IN THE PATIENTS PD CATHETER (NOT A FRESENIUS PRODUCT). THE PATIENT UNDERWENT PD CATHETER SURGERY ON (B)(6) 2022. THE PATIENT WAS CONTINUING TO COMPLETE PD THERAPY UTILIZING THE LIBERTY SELECT CYCLER. THE DATE OF THE PERITONITIS DIAGNOSIS WAS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. C-922894 (B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 870389 | PERITONEAL DIALYSIS | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |