FDA Adverse Event
Injury
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 3802243
·
Received May 9, 2014
Report
- Report Number
- 1416980-2014-14895
- Event Type
- Injury
- Date Received
- May 9, 2014
- Report Date
- April 15, 2014
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED INTRAPERITONEALLY WITH UNSPECIFIED ANTIBIOTICS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280577 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |