MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-07 for 7.5CM ANTERIOR/POSTERIOR RR 750 manufactured by Arthrocare Corp..
[126514621]
Patient Sequence No: 1, Text Type: N, H10
[126514622]
It was reported that when a rapid rhino was inserted the patient had developed a fibrin clot in her right nostril this persisted for a few weeks until the doctor took the patient to surgery and cauterized the nostril to prevent permanent impairment of body function or permanent damage to the patient's body structure. The patient currently has bip packing in her nose and continues to see the doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2018-00581 |
| MDR Report Key | 8046112 |
| Date Received | 2018-11-07 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2018-11-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 7.5CM ANTERIOR/POSTERIOR |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2018-11-07 |
| Catalog Number | RR 750 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-07 |