FDA Adverse Event
Malfunction
Summary report: N
PILLING CASTROVIEJO NH 8"
MDR report key: 1659437
·
Received April 9, 2010
Report
- Report Number
- 1044475-2010-00038
- Event Type
- Malfunction
- Date Received
- April 9, 2010
- Report Date
- March 15, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- HXK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE HAS BEEN REQUESTED, BUT NOT RECEIVED YET. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE DEVICE HAS BEEN REPORTED AS BROKEN. NO FURTHER INFO AVAILABLE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PILLING CASTROVIEJO NH 8" | CASTROVIEJO 8" | HXK | TELEFLEX MEDICAL | NA | MM8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |