D
Patient 1
PROBE COVER BROKE DURING EXAM/USE.
MAUDE MDR 8415850
- MDR report key
- 8415850
- Report number
- 8415850
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-09-27
- Date received
- 2019-03-13
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MICROTEK TRANSVAGINAL PROBE COVER | CABLE/LEAD/SENSOR/PROBE COVER, NON-STERILE | MICROTEK MEDICAL INC. | KKX | PC0907NB | 17262 | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-13 | 0 |