POLIGRIP FREE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2015-08-18 for POLIGRIP FREE manufactured by Glaxosmithkline Dungarvan Ltd..

Event Text Entries

[23984055] Additional info included, the consumer reported that she had some skin rip off her gums and cause bleeding when she removed her dentures after she used poligrip. She also advised that she experienced a lot of pain and suffering because of this issue. The consumer also indicated that she was a first time user of this product. Follow up case was received from the consumer on (b)(4) 2015. The consumer returned 1 tube of poligrip free and provided the lot number and expiration for the product, lot v13444a and expiration october 2016. She reported that her condition was getting better since the initial report. She also indicated that she had a hospital visit and they could not do anything since the initial report. She also advised that she intended to see her denturist for an appointment on (b)(6) 2015. She reported that she saw an health care professional for her condition and indicated that she was prescribed tramadol for pain for her condition. The action taken of poligrip free was withdrawn.
Patient Sequence No: 1, Text Type: N, H10


[23984056] Bleeding [hemorrhage]. Skin ripping off gums [gingival recession]. Pain. Suffering. Case description: this case was reported by a consumer via call center representative and described the occurrence of gingival recession in a (b)(6) female pt who received gsk denture adhesive (formulation unk) (poligrip unk) unk for product used for unk indication. Concurrent medical conditions included diabetes, caffeine consumption (1 cup of coffee a day for many years) and denture wearer. On an unk date, the pt started poligrip unk. On (b)(6) 2015, an unk time after starting poligrip unk, the pt experienced gingival recession, hemorrhage (serious criteria gsk medically significant), pain and suffering. On an unk date, the outcome of the gingival recession, hemorrhage, pain and suffering were unk. It was unk if the reporter considered the gingival recession, hemorrhage, pain and suffering to be related to poligrip unk.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003721894-2015-00002
MDR Report Key5020838
Report SourceCONSUMER,FOREIGN,OTHER
Date Received2015-08-18
Date of Report2015-06-26
Date of Event2015-06-25
Date Mfgr Received2015-07-21
Date Added to Maude2015-08-21
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 277090000
Manufacturer CountryUS
Manufacturer Postal277090000
Manufacturer Phone8888255249
Manufacturer G1GSK
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePOLIGRIP FREE
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-08-18
Lot NumberV13444A
Device Expiration Date2016-10-01
OperatorLAY USER/PATIENT
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 2015-08-18

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