MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for FINESSE 4100018 manufactured by Ameda.com.
[184743909]
The product involved in the complaint was not returned for investigation at this time despite 3 follow up messages to the customer.. Therefore, no conclusions can be made as to the cause or the event. Should additional information or the original product be received resulting in new, changed or corrected information, a follow-up report will be filed at that time.
Patient Sequence No: 1, Text Type: N, H10
[184743910]
Customer contacted ameda, inc. On 02/24/2020 to report the finesse pump she uses stopped functioning properly on friday (b)(6) 2020 when she prepared to pump at home. She usually plugs the ac adapter into one of the electrical outlets at home and starts pump operating before placing it to her breasts. She had momentarily walked away from the pump and when she returned, she saw sparking from the ac adapter end in the electrical outlet. She then saw the black casing above the prongs break apart and burst into flames. Mom quickly pulled the cord out of the outlet. Flames died out and sparking stopped. Mom reports no injury to herself or others in the house. Mom reports pump will not power on with batteries. A replacement finesse pump and ac adapter was shipped overnight to customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009974348-2020-00350 |
| MDR Report Key | 9874478 |
| Report Source | CONSUMER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2018-03-22 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 9642620261 |
| 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 | 2020-03-24 |
| Model Number | 4100018 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMEDA.COM |
| Manufacturer Address | 485 HALF DAY RD. SUITE 320 BUFFALO GROVE, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |