FDA Adverse Event
Other
Summary report: N
MST I/A TIP
MDR report key: 3075017
·
Received April 16, 2013
Report
- Report Number
- 3019924-2013-00015
- Event Type
- Other
- Date Received
- April 16, 2013
- Report Date
- April 16, 2013
- Manufacturer
- MICROSURGICAL TECHNOLOGY, INC.
- Product Code
- HMX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PART NUMBER AND LOT NUMBER OF THE DEVICES INVOLVED WERE NOT KNOWN AT THE TIME OF THIS REPORT. THE DEVICES WERE TESTED BY THE DISTRIBUTOR AT NELSON LABORATORIES AND WERE FOUND TO BE NEGATIVE FOR BACTERIAL ENDOTOXINS. THE PTS WERE REPORTED TO BE DOING WELL.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT THEIR CUSTOMER HAD AN INCREASE IN POST OPERATIVE INFLAMMATION, THOUGHT TO BE TASS ASSOCIATED WITH MST I/A TIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163099 | MST I/A TIP | IRRIGATION AND ASPIRATION CANNULA | HMX | MICROSURGICAL TECHNOLOGY, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |