FDA Adverse Event
Other
Summary report: N
UNIFINE PENTIPS
MDR report key: 2729294
·
Received February 23, 2012
Report
- Report Number
- 9612764-2012-00001
- Event Type
- Other
- Date Received
- February 23, 2012
- Report Date
- February 13, 2012
- Manufacturer
- OWN MUMFORD LTD
- Product Code
- FMI
- PMA / PMN Number
- K973899
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
WE SUPPOSE THAT THE PERFORMED INVESTIGATION WAS NOT INVASIVE AND WE CONSIDER STRANGE THE FACT THAT THE NEEDLE WASN'T FOUND. MAYBE IT HAS BROKEN, BUT IT DID NOT REMAIN INSIDE THE PT. NO OTHER RELATED COMPLAINTS WERE RAISED AGAINST THIS LOT. ALL THE ANALYSIS PERFORMED ON THE OTHER SAMPLE OF THE SAME LOT HAVE NOT GIVEN ANY DEFECTS.
Description of Event or Problem · 1
THE PEN NEEDLE HAS BROKEN INSIDE THE STOMACH OF THE PT (B)(4). THE NEEDLE HAS BROKEN AND THE DOCTOR HASN'T FOUND IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIFINE PENTIPS | UNIFINE | FMI | OWN MUMFORD LTD | 0903724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |