MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies Srl.
| Report Number | 3005477219-2019-00004 |
| MDR Report Key | 8691282 |
| Date Received | 2019-06-12 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-05-14 |
| Date Added to Maude | 2019-06-12 |
| 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 | MS STEFANIA TRIVA |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA, ITALY 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer G1 | COPAN FLOCK TECHNOLOGIES SRL |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA, |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLOQSWAB |
| Generic Name | APPLICATOR, ABORBENT TIPPED, STERILE, PRODUCT CODE: KXG |
| Product Code | KXG |
| Date Received | 2019-06-12 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | 1814374 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCK TECHNOLOGIES SRL |
| Manufacturer Address | VIA F. PEROTTI 16-18 BRESCIA, 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-12 |