D
Patient 1
PATIENT HAD EXCESSIVE BLEEDING FROM DRAINS, 2 HOURS AFTER MASTECTOMY SURGERY. PATIENT WAS TAKEN BACK TO OPERATING ROOM TO STOP BLEEDING.
MAUDE MDR 3579351
- MDR report key
- 3579351
- Report number
- 1226420-2014-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-12-10
- Date received
- 2014-01-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KAYLEE BOISVERT
- Address
- 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US
- Phone
- 603-603-6038
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GENERATOR PULSAR | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER | MEDTRONIC ADVANCED ENERGY, LLC | MUL | PS100-100 | PS100-100 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-01-16 | 0 |
Event Narratives#
N
Patient 1
(B)(4). GENERATOR STILL IN USE AND FACILITY NOT RETURNING FOR INVESTIGATION. (B)(4).
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.