MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-27 for MEDI-VAC ? FLEX ADVANTAGE? + GEL-VAC - 1000 ML 65651910PG manufactured by Cardinal Health Malta 212 Ltd.
| Report Number | 1423537-2019-00329 |
| MDR Report Key | 8742041 |
| Date Received | 2019-06-27 |
| Date of Report | 2019-06-27 |
| Date of Event | 1980-01-01 |
| Date Mfgr Received | 2019-06-04 |
| Device Manufacturer Date | 2017-04-06 |
| Date Added to Maude | 2019-06-27 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | CARDINAL HEALTH MALTA 212 LTD |
| Manufacturer Street | A51, INDUSTRIAL ESTATE |
| Manufacturer City | MARSA MRS3000 |
| Manufacturer Country | MT |
| Manufacturer Postal Code | MRS3000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDI-VAC ? FLEX ADVANTAGE? + GEL-VAC - 1000 ML |
| Generic Name | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
| Product Code | GCX |
| Date Received | 2019-06-27 |
| Model Number | 65651910PG |
| Catalog Number | 65651910PG |
| Lot Number | 17D01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH MALTA 212 LTD |
| Manufacturer Address | A51, INDUSTRIAL ESTATE MARSA MRS3000 MT MRS3000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-27 |