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 |