SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-31 for SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM manufactured by Gsk Dungarvan Stafford Miller.

Event Text Entries

[20019243] Zinc poisoning [metal poisoning]. Case description: this case was reported by a other health professional and described the occurrence of metal poisoning in a (b)(6) female patient who received triple salt dental adhesive cream (super poligrip original denture adhesive cream) cream for an unknown indication. On an unknown date, the patient started super poligrip original denture adhesive cream. On an unknown date, an unknown time after starting super poligrip original denture adhesive cream, the patient experienced metal poisoning (serious criteria gsk medically significant). Super poligrip original denture adhesive cream was discontinued (dechallenge was negative). On an unknown date, the outcome of the metal poisoning was not recovered/not resolved. The reporter considered the metal poisoning to be related to super poligrip original denture adhesive cream. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details: us report. Ae information received 26 march 2015: hcp called regarding treatment of female patient for zinc poisoning that patient attributed to use of an unknown variant of super poligrip. Hcp agreed to make patient aware of request for additional information and case number was given for reference. No follow up will be sent out at this time since no contact details are available at this time for the hcp reporter.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9681138-2015-00012
• MDR Report Key: 4652650
• Report Source: 05
• Date Received: 2015-03-31
• Date of Report: 2015-03-26
• Date Mfgr Received: 2015-03-26
• Date Added to Maude: 2015-04-03
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: PO BOX 13398
• Manufacturer City: RESEARCH TRIANGLE PARK NC 27709
• Manufacturer Country: US
• Manufacturer Postal: 27709
• Manufacturer Phone: 8888255249
• Manufacturer G1: GSK
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM
• Generic Name: DENTURE ADHESIVE
• Product Code: KOL
• Date Received: 2015-03-31
• Operator: LAY USER/PATIENT
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GSK DUNGARVAN STAFFORD MILLER
• Manufacturer Address: DUNGARVAN EI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-03-31