MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for MECTA ECT INSTRUMENT manufactured by Mecta Corporation.
[139112225]
Basically, there was no supportive information of any kind to the claim. The device listed was not a product of somatics. The complainant did not respond to questions sent and delivered to the submitted address. [mw5081540].
Patient Sequence No: 1, Text Type: N, H10
[139112226]
On (b)(6) 2019 there was an anonymous report filled to the medwatch maude section. It claimed many adverse events produced over a long period of time. It referenced mecta corporation and the mecta device as the manufacture, but it also listed somatics on the report, even though the somatics medical device was not listed. See the maude report dated (b)(6) 2018 for more details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420295-2019-00001 |
| MDR Report Key | 8429639 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-18 |
| Date of Event | 2018-11-17 |
| Date Facility Aware | 2018-12-11 |
| Report Date | 2018-11-17 |
| Date Reported to FDA | 2018-11-17 |
| Date Reported to Mfgr | 2018-12-11 |
| Date Mfgr Received | 2018-12-11 |
| Date Added to Maude | 2019-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID MIRKOVICH |
| Manufacturer Street | 720 COMMERCE DRIVE SUITE 101 |
| Manufacturer City | VENICE FL 34292 |
| Manufacturer Country | US |
| Manufacturer Postal | 34292 |
| Manufacturer Phone | 8472346761 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | MW5081540 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MECTA ECT INSTRUMENT |
| Generic Name | MECTA |
| Product Code | GXC |
| Date Received | 2019-03-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MECTA CORPORATION |
| Manufacturer Address | 19799 SW 95TH AVENUE TUALATIN OR 97062 US 97062 |
| Brand Name | MECTA ECT INSTRUMENT |
| Generic Name | MECTA |
| Product Code | GXC |
| Date Received | 2019-03-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTA CORPORATION |
| Manufacturer Address | 19799 SW 95TH AVENUE TUALATIN OR 97062 US 97062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |