FDA Adverse Event
Malfunction
Summary report: N
ULTRASOUND T-SHAPED PROBE COVER
MDR report key: 2485421
·
Received February 16, 2012
Report
- Report Number
- 8043817-2012-00002
- Event Type
- Malfunction
- Date Received
- February 16, 2012
- Report Date
- February 10, 2012
- Manufacturer
- MICROTEK MEDICAL, INCL.
- Product Code
- KKX
- PMA / PMN Number
- K882724
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MICROTEK HAS CONTINUED TO INQUIRE REGARDING DETAILS OF THIS EVENT. IT HAS BEEN CONFIRMED THAT THIS EVENT OCCURRED IN (B)(6). THE DISTRIBUTOR NOTED THAT "WE CANNOT PROVIDE INFO ABOUT PTS". MICROTEK'S INTERNAL INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
THE RUBBER PART OF THE PROBE COVER DETACHED FROM THE PLASTIC PART. NO ADVERSE EVENT. NO AFFECT OF PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRASOUND T-SHAPED PROBE COVER | DRAPE, SURGICAL | KKX | MICROTEK MEDICAL, INCL. | 15342-00 | D111081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |