MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-04-11 for RELIEVA FLEX SINUS GUIDE CATHETER GC110RF manufactured by Acclarent, Inc..
[42371695]
(b)(4). The lot history record(s) was reviewed and no anomalies were found related to this complaint. In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[42371696]
Acclarent was informed of an event which occurred right after the right maxillary sinus procedure on (b)(6) 2016, in which a relieva flex sinus guide catheter was use. The patient returned to the office with a minor reaction. The patient's right eye was completely closed and the patient could not open it. The physician consulted with the ophthalmologist who was not clear about the reaction. The patient returned to the office to have the physician examine the eye. There was no visual change reported and the patient did not experience pain. The patient was prescribed oral steroid and is reported to be well and has been doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2016-00008 |
| MDR Report Key | 5568783 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-11 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-03-18 |
| Date Added to Maude | 2016-04-11 |
| 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 | JOAQUIN KURZ |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497899383 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA FLEX SINUS GUIDE CATHETER |
| Generic Name | CANNULA, SINUS |
| Product Code | KAM |
| Date Received | 2016-04-11 |
| Catalog Number | GC110RF |
| Lot Number | 151103B-PC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-11 |