FDA Adverse Event
Malfunction
Summary report: N
MICROTEK
MDR report key: 14137024
·
Received April 18, 2022
Report
- Report Number
- 1043582-2022-00002
- Event Type
- Malfunction
- Date Received
- April 18, 2022
- Date of Event
- March 29, 2022
- Report Date
- April 18, 2022
- Manufacturer
- ECOLAB/MICROTEK MEDICAL INC.
- Product Code
- KME
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT SLID WHILE IN THE TRENDELENBERG POSTION. NO PATIENT INFECTION, INJURY, OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2043991 | MICROTEK | ABSORBANT TABLE COVER | KME | ECOLAB/MICROTEK MEDICAL INC. | ABTSLSF | 211005V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |