FDA Adverse Event
Injury
Summary report: N
GRANUFLO
MDR report key: 3111343
·
Received May 9, 2013
Report
- Report Number
- 3005162618-2013-00005
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- January 19, 2012
- Report Date
- April 9, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INFO PROVIDED, NO DEFINITIVE CONCLUSION CAN BE DRAWN. CURRENTLY, MEDICAL RECORDS HAVE NOT BEEN PROVIDED. PRODUCT IDENTIFIERS ARE UNK THEREFORE A MFG REVIEW CANNOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADD¿L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS ALLEGED THAT ON (B)(6) 2012 A PCT (PATIENT CARE TECHNICIAN) SPLASHED DIALYZER EFFLUENT INTO HER RIGHT EYE THAT GOT UNDER HER FACE SHIELD. SHE SOUGHT MEDICAL CARE FOR ONE VISIT ON THE SAME DATE. SHE HAS SINCE BEEN DISCHARGED FROM CARE WITH NO RESULTING DISABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204951 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other |