N
Patient 1
APPLIED MEDICAL HAS JUST RECEIVED THE EVENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.
MAUDE MDR 7049734
- MDR report key
- 7049734
- Report number
- 2027111-2017-02120
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-10-25
- Date received
- 2017-11-21
- 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
- WENDY KOBAYASHI
- Address
- 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
- Phone
- 949-949-9497
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | G6313, L ALEXIS O C-SEC RET 5/BX | KGW | APPLIED MEDICAL RESOURCES | KGW | G6313 | 101356801 | 1298996 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-11-21 | 0 |
Event Narratives#
D
Patient 1
PROCEDURE PERFORMED - LOWER SEGMENT CAESAREAN SECTION. INCISION SIZE MEASURED- 12.5 CM. ALEXIS INSERTED AND ROLLED DOWN. YELLOW PLACEMENT RING WAS FOLDED INWARDS, OBSTRUCTING THE OPERATING FIELD. WHILST BABY WAS DELIVERED, ALEXIS CAME OUT OF SITU. WHEN REINSERTING ALEXIS O C SECTION, IT WOULD NOT STAY IN PLACE. ANOTHER ALEXIS O C SECTION WAS USED. TYPE OF INTERVENTION - ANOTHER ALEXIS O C SECTION WAS USED. PATIENT STATUS -DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.