FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 2970002
·
Received February 15, 2013
Report
- Report Number
- 1225714-2013-00154
- Event Type
- Death
- Date Received
- February 15, 2013
- Date of Event
- January 28, 2012
- Report Date
- January 22, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER HAS REQUESTED ADDITIONAL INFO AND HAS NOT RECEIVED MEDICAL RECORDS TO DATE. IF/WHEN ADDITIONAL INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED (B)(4) EVENT REPORT #(B)(4) FROM THE FDA ON (B)(6) 2013. THE REPORT WAS SUBMITTED BY A DIALYSIS PT'S WIFE WHO ALLEGED, THE PT DIED SUDDENLY ON (B)(6) 2012 AFTER HAVING DIALYSIS THE DAY BEFORE OF SUDDEN CARDIAC ARREST. THE PT'S WIFE ALLEGED THIS WAS DIRECTLY RELATED TO THE PRODUCT USED DURING THE DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67620 | NATURALYTE | DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |