FDA Adverse Event
Other
Summary report: N
MST BARRETT V2 I/A TIP
MDR report key: 2162288
·
Received July 9, 2011
Report
- Report Number
- 3019924-2011-00013
- Event Type
- Other
- Date Received
- July 9, 2011
- Date of Event
- June 9, 2011
- Report Date
- July 7, 2011
- Manufacturer
- MICROSURGICAL TECHNOLOGY INC
- Product Code
- HQE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE OPERATED AS DESIGNED. THE DEVICE EVALUATION REVEALED GOUGING AND SCRATCHES BUT THESE SIGNS OF USE ARE NOT THOUGHT TO HAVE CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 1
THE DOCTOR REPORTED THAT A 1.5MM PUNCTURE OF THE CAPSULE CAUSED A CHANGE OF PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MST BARRETT V2 I/A TIP | IRRIGATION/ASPIRATION CANNULA | HQE | MICROSURGICAL TECHNOLOGY INC | BRT-1008 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |