MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-01 for FINESSE 4100018 manufactured by Ameda, Inc..
| Report Number | 3009974348-2019-00344 |
| MDR Report Key | 9265921 |
| Report Source | CONSUMER |
| Date Received | 2019-11-01 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-10-02 |
| Date Mfgr Received | 2019-10-03 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2019-11-01 |
| 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 | MRS. LINDA ZAGER |
| Manufacturer Street | 485 HALF DAY RD. SUITE 320 |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8479642620 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINESSE |
| Generic Name | ELECTRIC BREAST PUMP |
| Product Code | HGX |
| Date Received | 2019-11-01 |
| Returned To Mfg | 2019-10-29 |
| Model Number | 4100018 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMEDA, INC. |
| Manufacturer Address | 485 HALF DAY RD. SUITE 320 BUFFALO GROVE IL 60089 US 60089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-01 |