STIMULATOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-10 for STIMULATOR * manufactured by Unk.

Event Text Entries

[29008] Pt reports that although the oct medical bulletin stated cdrh seized more than a million dollars worth of "stimulators", the product is still being advertized on lengthy tv commercials. Using several well known persons to advocate the product, the commericals urge viewers to order the device by telephone. Rptr is concerned that older citizens are being billed by these tv promotions.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4001726
• MDR Report Key: 54455
• Date Received: 1996-12-10
• Date of Report: 1996-11-04
• Date Added to Maude: 1996-12-12
• 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: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STIMULATOR
• Generic Name: STIMULATOR
• Product Code: GZI
• Date Received: 1996-12-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 55016
• Manufacturer: UNK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-12-10