FDA Adverse Event
Injury
Summary report: N
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
MDR report key: 3841586
·
Received May 30, 2014
Report
- Report Number
- 1416980-2014-17488
- Event Type
- Injury
- Date Received
- May 30, 2014
- Date of Event
- December 4, 2013
- Report Date
- May 7, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED A PERITONEAL INFECTION MANIFESTED BY SLIGHT ABDOMINAL PAIN AND CLOUDY EFFLUENT. TREATMENT WAS NOT REPORTED. THE CAUSE OF PERITONEAL INFECTION WAS NOT REPORTED. OUTCOME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317939 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | EXTRANEAL AND PHYSIONEAL 40 1.36% |