N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9908806
- MDR report key
- 9908806
- Report number
- 1717344-2020-00372
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-22
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA HERNANDEZ
- Address
- 5920 LONGBOW DRIVE BOULDER CO 80301 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SONICISION | INSTRUMENT, ULTRASONIC SURGICAL | COVIDIEN MFG DC BOULDER | LFL | SCD48 | SCD48 | 60320114X | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD AN ACTIVATION ISSUE AND THE TIP BROKE DURING THE PROCEDURE. NOTHING FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.