N
Patient 1
NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.
MAUDE MDR 7976180
- MDR report key
- 7976180
- Report number
- 2027111-2018-00390
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-09-05
- Date received
- 2018-10-17
- 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 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-17 | 0 | 1. O |
Event Narratives#
D
Patient 1
NAME OF PROCEDURE BEING PERFORMED: TOTAL ABDOMINAL HYSTERECTOMY. DR PERFORMED A TAH FOR LARGE FIBROID UTERUS AND HAD BEEN MOBILISING SPECIMEN BEFORE INSERTING ALEXIS RETRACTOR DURING THE PROCEDURE. DR HAD PACKED AWAY THE BOWEL PRIOR TO INSERTING THE INNER RING BUT HAS MADE COMMENT THAT SHE BELIEVES THE INNER RING CAUSED BOWEL INJURY DURING THE PROCEDURE. SHE FOUND SLIGHT TEARING OF THE SIGMOID, TRANSVERSE CUT, LATER IN THE PROCEDURE BUT PATIENT IS DOING WELL. SALES REP WILL BE ATTENDING FUTURE TAH CASES WHERE THE SURGEON WANTS TO USE THE ALEXIS WITH NEW SALES REP TO SUPPORT SURGEON AND COVER APPROPRIATE STEPS FOR INSERTION/REMOVAL. PATIENT STATUS: SLIGHT TEARING OF THE SIGMOID, BUT PATIENT IS DOING WELL TYPE OF INTERVENTION: UNKNOWN