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 8074337
- MDR report key
- 8074337
- Report number
- 2027111-2018-00427
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-10-19
- Date received
- 2018-11-15
- 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 | C8404, XL ALEXIS O WND PROT/RET 5/BX | KGW | APPLIED MEDICAL RESOURCES | KGW | C8404 | UNK | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-15 | 0 |
Event Narratives#
D
Patient 1
PROCEDURE PERFORMED: EXPLORATORY LAPARATOMY. THE DEVICE BROKE WHILE IN THE PATIENT'S ABDOMEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN IF THE MALFUNCTION OCCURRED WITH THE OUTER OR INNER RING. UNKNOWN IF THE SHEATH TORE, BROKE, OR SEPARATED. UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM ACCOUNT MANAGER ON FRIDAY, (B)(6) 2018: DON?T REMEMBER THE LOT NUMBER OR ANYTHING AND NO NEED FOR REPLACEMENT; ALL PRODUCT WAS REMOVED; HAPPENED WHILE IT WAS DEPLOYED IN THE ABDOMEN AND IMMEDIATELY NOTICED SINCE OUR RETRACTION WAS LOST; WE DID USE HANDHELD RICH RETRACTORS IN ADDITION TO THE RING. THE MALFUNCTION WAS AT THE SHEATH, WHERE THE SHEATH CONNECTS TO THE GREEN PLACEMENT RING. NO PATIENT INJURY. ALL PRODUCT WAS REMOVED.