FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 3710243
·
Received March 25, 2014
Report
- Report Number
- 1225714-2014-01040
- Event Type
- Death
- Date Received
- March 25, 2014
- Date of Event
- September 27, 2006
- Report Date
- February 27, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1222714-2014-01039 AND 1225714-2014-01040. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR'S #1225714-2014-01039 AND 1225714-2014-01040.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED UNKNOWN DATE AFTER THE USE OF THE PRODUCT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC EVENT AND EXPIRED, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176211 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |