FDA Adverse Event
Injury
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 3243901
·
Received July 23, 2013
Report
- Report Number
- 1416980-2013-19521
- Event Type
- Injury
- Date Received
- July 23, 2013
- Report Date
- June 28, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE TREATMENT FOR PERITONITIS WAS NOT REPORTED. OUTCOME OF PERITONITIS WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343058 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O | UNKNOWN DIANEAL |