FDA Adverse Event
Injury
Summary report: N
MICROTEK
MDR report key: 15583892
·
Received October 11, 2022
Report
- Report Number
- 8043817-2022-00028
- Event Type
- Injury
- Date Received
- October 11, 2022
- Date of Event
- September 26, 2022
- Report Date
- October 12, 2022
- Manufacturer
- ECOLAB/MICROTEK MEDICAL INC.
- Product Code
- PUI
- UDI-DI
- 00748426007752
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT A FOREIGN BODY, PRESUMED TO BE TAPE FROM THE CAMERA DRAPE, WAS RETAINED IN THE PATIENT. INTERVENTION WAS REQUIRED TO REMOVE THE RETAINED FOREIGN BODY FROM THE PATIENT. NO PATIENT INJURY OR INFECTION RESULTING FROM THE RETAINED FOREIGN BODY WAS REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A FOREIGN BODY, PRESUMED TO BE TAPE FROM THE CAMERA DRAPE, WAS RETAINED IN THE PATIENT. INTERVENTION WAS REQUIRED TO REMOVE THE RETAINED FOREIGN BODY FROM THE PATIENT. NO PATIENT INJURY OR INFECTION RESULTING FROM THE RETAINED FOREIGN BODY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2352066 | MICROTEK | CAMERA DRAPE | PUI | ECOLAB/MICROTEK MEDICAL INC. | 3501 | D213161 | 00748426007752 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |