FDA Adverse Event
Malfunction
Summary report: N
LARGE DIAMETER LACRIMAL INTUBATION SET/ STENTUBE OR LACRIMAL
MDR report key: 792191
·
Received November 27, 2006
Report
- Report Number
- 1649914-2006-00130
- Event Type
- Malfunction
- Date Received
- November 27, 2006
- Report Date
- November 27, 2006
- Manufacturer
- QUEST MEDICAL, INC.
- Product Code
- HNW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DR REPORTED THAT HE IS EXPERIENCING "CHEESE-WIRING" WITH THE STENTUBES. NO SAMPLES WERE SAVED; NO LOT NUMBERS WERE REPORTED. PRODUCT CODE IS EITHER LIS052 OR LIS27T.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LARGE DIAMETER LACRIMAL INTUBATION SET/ STENTUBE OR LACRIMAL | MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL PROBE | HNW | QUEST MEDICAL, INC. | LIS052 OR LIS27T | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |