MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-28 for PNSA STARTER BP EN ES USA 101035077 manufactured by Medela Llc.
| Report Number | 1419937-2020-00016 |
| MDR Report Key | 9768800 |
| Report Source | CONSUMER |
| Date Received | 2020-02-28 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-09-20 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4358316 |
| Manufacturer G1 | MEDELA LLC |
| Manufacturer Street | 1101 CORPORATE DR |
| Manufacturer City | MCHENRY, IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNSA STARTER BP EN ES USA |
| Generic Name | PUMP, BREAST, POWERED |
| Product Code | HGX |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 101035077 |
| Catalog Number | 101035077 |
| Lot Number | 456726 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA LLC |
| Manufacturer Address | 1101 CORPORATE DR MCHENRY, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |