FDA Adverse Event
Malfunction
Summary report: N
ULTRASOUND T-SHAPED PROBE COVER
MDR report key: 2485411
·
Received February 16, 2012
Report
- Report Number
- 8043817-2012-00004
- Event Type
- Malfunction
- Date Received
- February 16, 2012
- Report Date
- February 7, 2012
- Manufacturer
- MICROTEK MEDICAL, INC.
- 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 PATIENTS." 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 ON PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRASOUND T-SHAPED PROBE COVER | DRAPE, SURGICAL | KKX | MICROTEK MEDICAL, INC. | 15342-00 | D101811 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |