FDA Adverse Event
Injury
Summary report: N
NATURALYTE
MDR report key: 3841100
·
Received May 13, 2014
Report
- Report Number
- 1225714-2014-02562
- Event Type
- Injury
- Date Received
- May 13, 2014
- Date of Event
- February 4, 2005
- Report Date
- April 17, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-02561 AND 1225714-2014-02562.
Additional Manufacturer Narrative · 1
(B)(4). THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-02561 AND 1225714-2014-02562. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THE PLAINTIFF EXPERIENCED AN UNSPECIFIED INJURY ON AN UNKNOWN DATE AFTER USE OF THE PRODUCT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED NOTED THE PATIENT EXPERIENCED ALKALOSIS, CARDIAC ARRHYTHMIAS, AND SUDDEN CARDIAC ARREST, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285477 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |