MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for ECT manufactured by Unk.
[184153845]
(b)(6) hosp failed to obtain medical reports from (b)(6) hosp in (b)(6) where i was struck by 2 vehicles causing mild traumatic brain injury with behavioral abnormalities which is common after a concussion when struck by vehicles as a pedestrian. The (b)(6) hosp failed to obtain my medical record from (b)(6) which i agreed that they could obtain. If they had followed the treatment advised by (b)(6) for mild traumatic injury they wouldn't have diagnosed me with bipolar and over medicated me along with ect which was severely disabled me. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093794 |
| MDR Report Key | 9840651 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-13 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECT |
| Generic Name | DEVICE, ELECTROCONVULSIVE THERAPY |
| Product Code | GXC |
| Date Received | 2020-03-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2020-03-16 |