FDA Adverse Event
Injury
Summary report: N
LOFRIC ORIGO
MDR report key: 3703436
·
Received March 10, 2014
Report
- Report Number
- 3009632672-2014-00003
- Event Type
- Injury
- Date Received
- March 10, 2014
- Report Date
- February 17, 2014
- Manufacturer
- WELLSPECT HEALTHCARE A DIVISION OF DENTSPLY IH AB
- Product Code
- EZD
- PMA / PMN Number
- K122078
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
BASED UPON THE PRODUCT TESTING, THIS COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. WE HAVE RECEIVED AND ANALYZED SAMPLES. NOR THESE RESULTS OR THE BATCH DOCUMENTATION REVEALS DEFECTS OR DEVIATIONS. WE HAVE NOT HAD ANY OTHER COMPLAINTS ON THIS BATCH. SHOULD ADD'L INFO BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINS THAT AFTER CATHETERIZATION HE HAD A BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143650 | LOFRIC ORIGO | CATHETER, STRAIGHT (EZD) | EZD | WELLSPECT HEALTHCARE A DIVISION OF DENTSPLY IH AB | 44312 | 148594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |