N
Patient 1
A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
MAUDE MDR 6299125
- MDR report key
- 6299125
- Report number
- 1644019-2017-00111
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-01-18
- Date received
- 2017-02-03
- 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
- MS. RITA LOPEZ
- Address
- 6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
- Phone
- 817-817-8175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) | TUBING, NONINVASIVE | ALCON RESEARCH, LTD. - HOUSTON | GAZ | NA | 8065750957 | 1926002H | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-03 | 0 | 1. O |
Event Narratives#
D
Patient 1
A NURSE MANAGER REPORTED THAT DURING A VITRECTOMY PROCEDURE, THE SURGEON INDICATED THAT THE CANNULA DISCONNECTED FROM THE SYRINGE WHEN EXERTING PRESSURE TO INFUSE THE SILICONE OIL. THIS OCCURRED WITH TWO DIFFERENT UNITS. THE PROCEDURE WAS COMPLETED BY INFUSING THE SILICONE OIL SLOWLY AND WITH THE ASSISTANCE OF FORCEPS TO HOLD THE CONNECTION. THE PRODUCT SAMPLES WERE NOT RETAINED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.
N
Patient 1
THE LOT COMPLAINT HISTORY WAS REVIEWED; THIS IS THE FIRST COMPLAINT FOR THE FINISH GOODS LOT AND FIRST FOR THIS ISSUE. THE DEVICE HISTORY RECORD SHOWED THE PRODUCT WAS RELEASED PER SPECIFICATIONS. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECTION OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED AS A SAMPLE HAS NOT BEEN RECEIVED. POTENTIAL ROOT CAUSES COULD BE RELATED TO SURGICAL TECHNIQUE OR MANUFACTURING RELATED ISSUE, HOWEVER, THIS CANNOT BE CONFIRMED WITH THE INFORMATION AVAILABLE. AFTER A THOROUGH INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT NO ACTION WILL BE TAKEN AT THIS TIME. (B)(4).