SUPER POLIGRIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-09 for SUPER POLIGRIP manufactured by Glaxosmithkline Dungarvan Ltd..

Event Text Entries

[24653113] Possible zinc poisoning [metal poisoning], sick [sickness], nausea. Case description: this case was reported by a consumer 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 denture wearer. Co-suspect products included double salt dental adhesive cream (super poligrip) cream for denture wearer and denture adhesive powder-double salt (super poligrip denture adhesive powder) oral powder (batch number: n13414, expiry date unk) for denture wearer. The patient's past medical history included dental implantation. On an unk date, the patient started super poligrip original denture adhesive cream, super poligrip and super poligrip denture adhesive powder. On an unk date, an unk time after starting super poligrip original denture adhesive cream, super poligrip and super poligrip denture adhesive powder, the patient experienced metal poisoning (serious criteria gsk medically significant), sickness and nausea. Super poligrip original denture adhesive cream, super poligrip were discontinued (dechallenge was negative). Super poligrip denture adhesive powder was continued with no change. On an unk date, the outcome of the metal poisoning, sickness and nausea were not recovered/not resolved. The reporter considered the metal poisoning, sickness and nausea to be related to super poligrip original denture adhesive cream, super poligrip and super poligrip denture adhesive powder. Additional details: ae info received via phone 06/02/2015: the consumer stated that she had her upper plate when she was (b)(6) and has been using super poligrip cream since then. She had some implants done in the 70's and has a partial plate since then. She is getting sick and is nauseated most of the time she uses it. She feels that she might have zinc poisoning from using super poligrip cream all these years. She recently switched to super poligrip powder and the events continue. She is going to see her doctor and get blood work done to check her zinc levels.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9681138-2015-00022
• MDR Report Key: 4863399
• Report Source: 04
• Date Received: 2015-06-09
• Date of Report: 2015-06-02
• Date Mfgr Received: 2015-06-02
• Date Added to Maude: 2015-06-30
• 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
• Generic Name: DENTURE ADHESIVE
• Product Code: KOL
• Date Received: 2015-06-09
• Operator: LAY USER/PATIENT
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GLAXOSMITHKLINE DUNGARVAN LTD.
• Manufacturer Address: DUNGARVAN EI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-06-09