FDA Adverse Event
Injury
Summary report: N
PHACO TIP MST .9MM 15 DEG STRAIGHT
MDR report key: 2554669
·
Received April 27, 2012
Report
- Report Number
- 3019924-2012-00010
- Event Type
- Injury
- Date Received
- April 27, 2012
- Date of Event
- March 27, 2012
- Report Date
- April 27, 2012
- Manufacturer
- MICROSURGICAL TECHNOLOGY, INC.
- Product Code
- HQC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION. NO FURTHER DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
COMPANY DISTRIBUTOR REPORTED THAT THE SURGEON WAS EXPERIENCING AN INCREASE IN CORNEAL WOUND BURNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHACO TIP MST .9MM 15 DEG STRAIGHT | PHACO TIP | HQC | MICROSURGICAL TECHNOLOGY, INC. | PT-27915 | 042236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |