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 2019-09-13 for RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT RSP0616MFSN manufactured by Acclarent, Inc..
Report Number | 3005172759-2019-00123 |
MDR Report Key | 9041309 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-09-13 |
Date of Report | 2019-08-19 |
Date of Event | 2019-08-19 |
Date Mfgr Received | 2019-08-19 |
Device Manufacturer Date | 2019-03-29 |
Date Added to Maude | 2019-09-13 |
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 | MR. GABRIEL ALFAGEME |
Manufacturer Street | 31 TECHNOLOGY DRIVE |
Manufacturer City | IRVINE CA 92618 |
Manufacturer Country | US |
Manufacturer Postal | 92618 |
Manufacturer Phone | 949789-868 |
Manufacturer G1 | ACCLARENT, INC. |
Manufacturer Street | 33 TECHNOLOGY DRIVE |
Manufacturer City | IRVINE CA 92618 |
Manufacturer Country | US |
Manufacturer Postal Code | 92618 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT |
Generic Name | RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM |
Product Code | LRC |
Date Received | 2019-09-13 |
Catalog Number | RSP0616MFSN |
Lot Number | 190329A-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 92618 US 92618 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-09-13 |