FDA Adverse Event
Malfunction
Summary report: N
LARGE DIAMETER LACRIMAL INTUBATION SET/STENTTUBE
MDR report key: 703008
·
Received April 12, 2006
Report
- Report Number
- 1649914-2006-00024
- Event Type
- Malfunction
- Date Received
- April 12, 2006
- Report Date
- March 30, 2006
- Manufacturer
- QUEST MEDICAL, INC.
- Product Code
- HNW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE LARGE STENTUBES BREAK TOO OFTEN WHEN BEING PULLED THROUGH EVEN IF OINTMENT IS APPLIED FIRST. THE PRODUCT WAS NOT SAVED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LARGE DIAMETER LACRIMAL INTUBATION SET/STENTTUBE | MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL PROBE | HNW | QUEST MEDICAL, INC. | LIS052 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |