N
Patient 1
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MAUDE MDR 9903505
- MDR report key
- 9903505
- Report number
- 1416980-2020-01865
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-11
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
- Phone
- 224-224-2242
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NI | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | BAXTER HEALTHCARE CORPORATION | KDJ | NA | NI | NI | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. H |
Event Narratives#
D
Patient 1
A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF AND THE TREATMENT FOR THE EVENT WERE NOT REPORTED. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT HAS NOT RECOVERED FROM THE EVENT. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AS THE REPORTER DECLINED FOLLOW UP.