N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 8377475
- MDR report key
- 8377475
- Report number
- 1219930-2019-01193
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-28
- Date received
- 2019-02-28
- 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
- 60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 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 | SURGINEEDLE | PNEUMOPERITONEUM NEEDLE | COVIDIEN LP LLC NORTH HAVEN | FHO | 172015 | 172015 | N8D0872X | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-28 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE BEGINNING OF SURGERY FOR PNEUMOPERITONEUM FORMATION, THE DEVICE WAS NOT ABLE TO PIERCE THE TISSUE. THE PRODUCT HAS BEEN EXCHANGE FOR OTHER DEVICE OF THE SAME CODE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.