N
Patient 1
(B)(6).
MAUDE MDR 5644612
- MDR report key
- 5644612
- Report number
- 3006524618-2016-00107
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-04-19
- Date received
- 2016-05-10
- 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
- JIM GONZALES
- Address
- 7000 W. WILLIAM CANNON AUSTIN TX 78735 US
- Phone
- 512-512-5123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 7.5CM ANTERIOR/POSTERIOR | BALLOON, EPISTAXIS | ARTHROCARE CORP. | EMX | RR750 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-10 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE RAPID RHINO FELL APART IN THE PATIENT'S NOSE MAKING REMOVAL DIFFICULT. THERE HAVE BEEN NO REPORTED PATIENT COMPLICATIONS.
N
Patient 1
VISUAL EXAMINATION AND MATERIALS TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRESENCE OF NYLON IN THE CMC/NYLON KNIT ON THE RR 750 DEVICE. THE PRESENCE OF NYLON CONFIRMS THAT THERE WAS NOT A PRODUCTION ERROR DURING MANUFACTURING. THE DESIGN OF THE DEVICE REQUIRES THE NYLON IN THE CMC/NYLON KNIT TO RE-ENFORCE THE FABRIC. THIS KEEPS IT INTACT DURING PLACEMENT/USE. THUS, THE COMPLAINT COULD NOT BE VERIFIED, NOR COULD A ROOT CAUSE BE DETERMINED WITH CONFIDENCE. FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT IS THE PATIENT FOLLOWING POST-OPERATIVE INSTRUCTIONS, DEVICE NOT WETTED PER IFU PRIOR TO PLACEMENT, DEVICE WETTED WITH SOLUTION OTHER THAN STERILE WATER, OR TECHNIQUE IN THE REMOVAL PROCESS. THE INSTRUCTIONS FOR USE (IFU) OUTLINES WARNING, PRECAUTIONARY MEASURES AND INSTRUCTIONS REGARDING THE USE OF THE PRODUCT. THERE WERE NO INDICATIONS TO SUGGEST THE PRODUCT DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.