MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-03 for THOPAZ+ PUMP SALE 0791000 manufactured by Medela Ag.
| Report Number | 1419937-2019-00114 |
| MDR Report Key | 8956178 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-09-03 |
| Date Mfgr Received | 2019-05-24 |
| Device Manufacturer Date | 2016-10-12 |
| Date Added to Maude | 2019-09-03 |
| 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 | JAN KLOIBER |
| Manufacturer Street | 1101 CORPORATE DRIVE |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer G1 | MEDELA AG |
| Manufacturer Street | LATTICHSTRASSE 4B |
| Manufacturer City | BAAR 6341, |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THOPAZ+ PUMP SALE |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2019-09-03 |
| Returned To Mfg | 2019-05-24 |
| Model Number | 0791000 |
| Catalog Number | 0791000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA AG |
| Manufacturer Address | LATTICHSTRASSE 4B BAAR 6341, SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-03 |