N
Patient 1
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.
MAUDE MDR 6490416
- MDR report key
- 6490416
- Report number
- 1820334-2017-00651
- Event key
- 0
- Event type
- 3
- Date received
- 2017-04-13
- 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
- MRS. RITA HARDEN
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-13 | 0 |
Event Narratives#
D
Patient 1
INTERNATIONAL CUSTOMER / PATIENT REPORTED THAT THE CLAMP WAS BROKEN RESULTING IN LEAKAGE OF WATER FROM THE DEVICE. THE DEVICE IMPLANT DATE WAS NOT PROVIDED. THE LEAKAGE WAS OBSERVED IN THE CONNECTING TUBE. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO REPORTS BEING SUBMITTED AS THE REPORTER / PATIENT INDICATED TWO SEPARATE EVENTS. SEE MDR NUMBERS 1820334-2017-00650 AND 1820334-2017-00651 FOR EACH ASSOCIATED EVENT.
N
Patient 1
INVESTIGATION ? EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.