FDA Adverse Event
Death
Summary report: N
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
MDR report key: 3140607
·
Received May 31, 2013
Report
- Report Number
- 1416980-2013-13949
- Event Type
- Death
- Date Received
- May 31, 2013
- Date of Event
- August 26, 2012
- Report Date
- August 28, 2012
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- PMA / PMN Number
- K102936
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD PASSED AWAY. TWO DAYS PRIOR, THE PATIENT HAD EXHIBITED SYMPTOMS OF ABDOMINAL PAIN AND MALAISE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241012 | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | DIANEAL |