MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2005-10-12 for UNK * manufactured by Sunrise Machine And Tool, Inc..
[412427]
Rec'd many electro shock treatments. Several problems after ect including lack of balance, severe memory loss and insomnia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2132280-2005-00010 |
| MDR Report Key | 641638 |
| Report Source | 04,05,06,07 |
| Date Received | 2005-10-12 |
| Date of Report | 2005-10-12 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2005-10-11 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 2005-10-19 |
| 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 | 0 |
| Manufacturer Street | 1380 LEGION RD |
| Manufacturer City | DETROIT LAKES MN 56502 |
| Manufacturer Country | US |
| Manufacturer Postal | 56502 |
| Manufacturer Phone | 2184373386 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | ELECTRO SHOCK |
| Product Code | JXK |
| Date Received | 2005-10-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 2475558 |
| Manufacturer | SUNRISE MACHINE AND TOOL, INC. |
| Manufacturer Address | 1380 LEGION RD. DETROIT LAKES MN 56501 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2005-10-12 |