POLIGRIP ULTRA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2015-09-16 for POLIGRIP ULTRA manufactured by Glaxosmithkline Dungarvan Ltd.

Event Text Entries

[26965840] Zinc poisoning [metal poisoning]; sensation in her leg [abnormal sensation of limbs]; head spinning [head spinning]; loss of balance [balance difficulty]; fall; stomach pain; looked pale; bleeding lips [lip hemorrhage]; ill [unwell]; excessive use of product [overdose]; lack of effect [ lack of drug effect]. Case description: this case was reported by a consumer via call center representative and described the occurrence of metal poisoning in a (b)(6) year old female patient who received gsk denture adhesive (formulation unknown) (poligrip ultra) unknown for denture wearer. Concurrent medical conditions included deafness. On an unknown date, the patient started poligrip ultra. In 2015, an unknown time after starting poligrip ultra, the patient experienced metal poisoning (serious criteria gsk medically significant), abnormal sensation of limbs, head spinning, balance difficulty, fall, stomach pain, looked pale, lip hemorrhage, unwell, overdose and lack of drug effect. On an unknown date, the outcome of the metal poisoning, abnormal sensation of limbs, head spinning, balance difficulty and fall were not recovered/not resolved and the outcome of the stomach pain, looked pale, lip hemorrhage and unwell were recovered/resolved and the outcome of the overdose and lack of drug effect were not reported. It was unknown if the reporter considered the metal poisoning, abnormal sensation of limbs, head spinning, balance difficulty, fall, stomach pain, looked pale, lip hemorrhage, unwell, overdose and lack of drug effect to be related to poligrip ultra. Additional details: a call was received from a consumer regarding her mother who has been using poligrip ultra for over 20 years. The daughter reported that her mother had received new dentures approximately three months ago which failed to hold, her mother; therefore, applied more of the product to keep them in place. Subsequent to this she started to complain of stomach pains, "head spinning", sensation in leg, and loss of balance. She also felt ill and suffered a fall. The mother was diagnosed with zinc poisoning by her gp. At the time of reporting the events were unresolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003721894-2015-00008
MDR Report Key5108100
Report SourceCONSUMER,FOREIGN
Date Received2015-09-16
Date of Report2015-09-04
Date of Event2015-01-01
Date Mfgr Received2015-09-04
Date Added to Maude2015-09-28
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 FDA3
Event Location3
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 NamePOLIGRIP ULTRA
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-09-16
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKLINE DUNGARVAN LTD
Manufacturer AddressDUNGARVAN, WATERFORD EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-09-16

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.