DUALSTIM NS-2CA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-08 for DUALSTIM NS-2CA manufactured by Life-tech, Inc..

Event Text Entries

[92952] A 35 yr old female undergoing gastric 2. 5 cm superficial burns on left wrist. Burn sites were beneath surface electrodes connected to peripheral nerve stimulator.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number147995
MDR Report Key147995
Date Received1998-01-08
Date of Report1997-09-11
Date of Event1997-07-03
Date Facility Aware1997-07-03
Report Date1997-09-11
Date Reported to Mfgr1997-10-03
Date Added to Maude1998-02-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDUALSTIM
Generic NamePERIPHERAL NERVE STIMULATOR
Product CodeKOI
Date Received1998-01-08
Model NumberNS-2CA
Catalog NumberNI
Lot NumberNI
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key144207
ManufacturerLIFE-TECH, INC.
Manufacturer AddressP.O. BOX 36221 HOUSTON TX 772366221 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-01-08

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