N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 8482543
- MDR report key
- 8482543
- Report number
- 2647580-2019-01812
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-03-12
- Date received
- 2019-04-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- 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 | ENDO CLINCH II | FORCEPS, OBSTETRICAL | US SURGICAL PUERTO RICO | HDA | 174317 | 174317 | P8K1505PX | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-04 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS PREPARED DURING LAPAROSCOPIC CHOLECYSTECTOMY, THERE WAS A FEELING OF STRANGENESS AT THE TIP WHEN THE PRODUCT WAS TAKEN OUT FROM THE PACKAGE. AFTER CHECKING, THE ROOT OF THE JAWS WAS FOUND TO BE UNSTEADY AND WAS ABOUT TO COME OFF. A NEW PRODUCT WAS OPENED AND USED TO COMPLETE THE CASE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT.