FDA Adverse Event
Other
Summary report: N
DELTACUT
MDR report key: 1063708
·
Received June 19, 2008
Report
- Report Number
- 9611612-2008-00008
- Event Type
- Other
- Date Received
- June 19, 2008
- Date of Event
- May 28, 2008
- Report Date
- June 18, 2008
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- KNW
- PMA / PMN Number
- K063233
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVENT TOOK PLACE IN OTHER COUNTRY. NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE CURRENT DEVICE HISTORY RECORD AND THE RAW MATERIAL HISTORY FILES AS WELL AS POST MARKET SURVEILLANCE SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS DEVICE. BASED UPON INVESTIGATIONAL EFFORTS AND UPON THE END USERS NARRATIVE, THE INCIDENT IS EVALUATED TO BE A USER ERROR. THIS FILE IS CONSIDERED AS CLOSED.
Description of Event or Problem · 1
EVENT TOOK PLACE IN OTHER COUNTRY. FIRST ATTEMPT TO GAIN SPECIMEN FAILED DUE TO USER ERROR. SECOND ATTEMPT NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTACUT | CANNULA FOR SOFT TISSUE BIOPSY | KNW | PAJUNK GMBH MEDIZINTECHNOLOGIE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |