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 04 report with the FDA on 2015-06-09 for SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM manufactured by Glaxosmithkline Dungarvan Ltd.

Event Text Entries

[24653361] 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 them. 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 Number9681138-2015-00023
MDR Report Key4863420
Report Source04
Date Received2015-06-09
Date of Report2015-06-02
Date Mfgr Received2015-06-02
Date Added to Maude2015-06-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer StreetPO BOX 13398
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone8888255249
Manufacturer G1GSK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-06-09
OperatorLAY USER/PATIENT
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKLINE DUNGARVAN LTD
Manufacturer AddressDUNGARVAN EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-06-09

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