FDA Adverse Event
Malfunction
Summary report: N
MICROTEK MEDICAL INC.
MDR report key: 12623704
·
Received October 13, 2021
Report
- Report Number
- 8043817-2021-00004
- Event Type
- Malfunction
- Date Received
- October 13, 2021
- Date of Event
- September 29, 2021
- Report Date
- November 8, 2021
- Manufacturer
- MICROTEK MEDICAL INC.
- Product Code
- PUI
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT A HOLE WAS OBSERVED IN THE PROBE COVER WHEN IT WAS HANDED OFF INTO THE STERILE FIELD. NO INFECTION OR PATIENT INJURY WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HOLE OBSERVED IN THE PROBE COVER WHEN IT WAS HANDED OFF INTO THE STERILE FIELD. NO INFECTION OR PATIENT INJURY OR INFECTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1525528 | MICROTEK MEDICAL INC. | PROBE COVER | PUI | MICROTEK MEDICAL INC. | PC1291 | D210741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |