UNK *

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number2132280-2005-00010
MDR Report Key641638
Report Source04,05,06,07
Date Received2005-10-12
Date of Report2005-10-12
Date of Event2002-01-01
Date Mfgr Received2005-10-11
Device Manufacturer Date1997-01-01
Date Added to Maude2005-10-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street1380 LEGION RD
Manufacturer CityDETROIT LAKES MN 56502
Manufacturer CountryUS
Manufacturer Postal56502
Manufacturer Phone2184373386
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameELECTRO SHOCK
Product CodeJXK
Date Received2005-10-12
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key2475558
ManufacturerSUNRISE MACHINE AND TOOL, INC.
Manufacturer Address1380 LEGION RD. DETROIT LAKES MN 56501 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2005-10-12

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