FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 1130906
·
Received September 15, 2008
Report
- Report Number
- 9611369-2008-00749
- Event Type
- Injury
- Date Received
- September 15, 2008
- Manufacturer
- *
- Product Code
- KDI
- PMA / PMN Number
- K030592
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS NOT ARRIVED FOR INVESTIGATION YET. THE ROOT CAUSE WILL BE EVALUATED AFTER INVESTIGATION.
Description of Event or Problem · 1
A CHRONIC HEMODIALYSIS PT SUFFERED A SEVERE REACTION AT THE BEGINNING OF A ROUTINE DIALYSIS TREATMENT. THE PT PRESENTED WITH SEVERE RESPIRATORY DISTRESS REQUIRING IV MEDICATION (EPINEPHRINE, STEROIDS, BENADRYL) AND OXYGEN. THE PT WAS TRANSFERRED TO THE ICU FOR OVERNIGHT OBSERVATION BUT WAS DISCHARGED THE NEXT DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | KDI | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |