POLY-GRIP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-21 for POLY-GRIP * manufactured by *.

Event Text Entries

[290960] Consumer opened and used product from a new tube of poly-grip prior to going to work. The product had an off-taste (chemical). Consumer felt nauseous that day. Consumer switched back to the poly-grip-grip from a old tube after about four hours and the symptoms subsided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003555
• MDR Report Key: 476382
• Date Received: 2003-07-21
• Date of Report: 2003-06-02
• Date Added to Maude: 2003-08-11
• 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: POLY-GRIP
• Generic Name: POLY-GRIP DENTURE ADHESIVE
• Product Code: KOP
• Date Received: 2003-07-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 465209
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-07-21