N
Patient 1
SUBMIT DATE: 12/26/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 7145617
- MDR report key
- 7145617
- Report number
- 9612030-2017-05260
- Event key
- 0
- Event type
- 3
- Date received
- 2017-12-26
- 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
- EDWARD ALMEIDA
- Address
- 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
- Phone
- 508-508-5084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-12-26 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER STATES THAT THE TEAM HAS FOUND OUR SURGICAL MARKERS TO BE BLEEDING AND LEAVING A JAGGED LINE FOR THE INCISION PLACEMENT.