MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-14 for UNKNOWN manufactured by Arthrocare Corp..
[141903235]
Foreign zip code: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141903236]
It was reported that during procedure, the blue sheath of rapid rhino was not removed prior to insertion, producing septal abrasion and exacerbation of epistaxis in the patient. The patient was re-packed and sent home the next day. No further treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2019-00182 |
| MDR Report Key | 8512576 |
| Date Received | 2019-04-14 |
| Date of Report | 2019-05-20 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-04-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | UNKNOWN |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2019-04-14 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 1. Other | 2019-04-14 |