MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-05 for RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER N/A RV02 manufactured by Acclarent, Inc..
[44565251]
(b)(4). The lhr (lot history record) review cannot be performed as lot number was unavailable.
Patient Sequence No: 1, Text Type: N, H10
[44565252]
Acclarent was informed of an event that occurred on (b)(6) 2016, involving a relieva vortex 2 sinus irrigation catheter. The physician attempted to irrigate the maxillary sinus and the patient's orbit started to swell. The physician immediately ceased the irrigation and placed pressure on the eye. The ophthalmologist examined the patient and confirmed that there was no damage to the eye. The patient was fine and the procedure was completed. Acclarent tried to find out additional patient information; additional information is not available at this time. There was no report of any product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2016-00009 |
| MDR Report Key | 5636007 |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-12 |
| Date of Event | 2016-04-12 |
| Date Added to Maude | 2016-05-05 |
| 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 | 0 |
| Brand Name | RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER |
| Generic Name | IRRIGATOR, SINUS |
| Product Code | KAM |
| Date Received | 2016-05-05 |
| Model Number | N/A |
| Catalog Number | RV02 |
| Lot Number | UNK |
| 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; 2. Required No Informationntervention | 2016-05-05 |