MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for PACIFIC PLUS PCE060040090 manufactured by Invatec Spa.
| Report Number | 3004066202-2020-00014 |
| MDR Report Key | 9877771 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-05-24 |
| Date Added to Maude | 2020-03-25 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | INVATEC SPA |
| Manufacturer Street | VIA MARTIRI DELLA LIBERTA, 7 |
| Manufacturer City | RONCADELLE 25030 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 25030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PACIFIC PLUS |
| Generic Name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
| Product Code | LIT |
| Date Received | 2020-03-25 |
| Catalog Number | PCE060040090 |
| Lot Number | 1M003362 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVATEC SPA |
| Manufacturer Address | VIA MARTIRI DELLA LIBERTA, 7 RONCADELLE 25030 IT 25030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |