N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9908779
- MDR report key
- 9908779
- Report number
- 2647580-2020-01159
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-19
- 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
- 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 | GIA | STAPLE, IMPLANTABLE | US SURGICAL PUERTO RICO | GDW | GIA8048SBR | GIA8048SBR | 1813143G | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE DID NOT FIRE. THE RELOAD HAS NOT PROGRESSED. ANOTHER HANDLE AND THE SAME RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
ACCORDING TO THE REPORTER, DURING AN OPEN GASTRIC BYPASS PROCEDURE, THE DEVICE DID NOT FIRE. THE RELOAD HAS NOT PROGRESSED. ANOTHER HANDLE AND THE SAME RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.