N
Patient 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.
MAUDE MDR 6089200
- MDR report key
- 6089200
- Report number
- 0001825034-2016-04572
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-10-10
- Date received
- 2016-11-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. MEGAN HAAS
- Address
- 56 E. BELL DRIVE WARSAW IN 46582 US
- Phone
- 574-574-5743
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | REDI-FLOW FINE FILTER SYSTEM 6/CS | TUBING, NONINVASIVE | BIOMET BIOLOGICS | GAZ | N/A | 631040 | 216617 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-09 | 0 | 1. O |
Event Narratives#
D
Patient 1
THERE WAS A HOLE IN THE FILTER SYSTEM WHERE THE FILTER ATTACHES TO THE PLASTIC HOUSING UNIT WHICH CAUSED A DELAY IN THE PROCEDURE OF 1 TO 2 HOURS.
N
Patient 1
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. NO DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE FILTER WITH NO DEVIATIONS OR ANOMALIES BEING IDENTIFIED. PHOTOS OF THE DEVICE WERE RECEIVED AND REVIEWED. IT WAS FOUND THAT THERE WAS DAMAGE TO THE DEVICE, SO THE COMPLAINT IS CONSIDERED TO BE CONFIRMED; HOWEVER, IT IS UNKNOWN WHERE THE DAMAGE OCCURRED. THE REPORTED DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.