MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-08-20 for LUKI ASP TUBES 61/4 8886864604 manufactured by Covidiein.
| Report Number | 1282497-2019-08613 |
| MDR Report Key | 8911097 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-08-20 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2019-08-15 |
| Date Added to Maude | 2019-08-20 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUKI ASP TUBES 61/4 |
| Generic Name | CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION |
| Product Code | KDH |
| Date Received | 2019-08-20 |
| Model Number | 8886864604 |
| Catalog Number | 8886864604 |
| Lot Number | 182710205 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEIN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-20 |