MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-27 for BEMIS QUICK FIT 1500CC SUCTION LINER 1504 manufactured by Bemis De Mexico, Sa De Cv.
| Report Number | 3011198121-2019-00003 |
| MDR Report Key | 9130827 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-09-27 |
| Date of Report | 2019-09-27 |
| Date of Event | 2019-09-05 |
| Date Facility Aware | 2019-09-05 |
| Report Date | 2019-09-05 |
| Date Reported to Mfgr | 2019-09-05 |
| Date Mfgr Received | 2019-09-05 |
| Device Manufacturer Date | 2019-04-23 |
| Date Added to Maude | 2019-09-27 |
| 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 | MR RODOLFO VILLARREAL |
| Manufacturer Street | AV TEXAS #200 PARQUE INDUSTRIAL NACIONAL |
| Manufacturer City | CIENEGA DE FLORES, NUEVO LEON 65550 |
| Manufacturer Country | MX |
| Manufacturer Postal | 65550 |
| Manufacturer G1 | BEMIS DE MEXICO, SA DE CV |
| Manufacturer Street | AV TEXAS #200 PARQUE INDUSTRIAL NACIONAL |
| Manufacturer City | CIENEGA DE FLORES, 65550 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 65550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEMIS QUICK FIT 1500CC SUCTION LINER |
| Generic Name | SUCTION SYSTEM CANISER LINER |
| Product Code | GCX |
| Date Received | 2019-09-27 |
| Model Number | 1504 |
| Catalog Number | 1504 |
| Lot Number | 179890 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEMIS DE MEXICO, SA DE CV |
| Manufacturer Address | AV TEXAS #200 PARQUE INDUSTRIAL NACIONAL CIENEGA DE FLORES, 65550 MX 65550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-27 |