MAUDE Adverse Event Report: GSK DUNGARCAN STAFFORD MILLER SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA),; DENTURE ADHESIVE

Lot Number TP15207

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Diarrhea (1811); Hypersensitivity/Allergic reaction (1907); Irritation (1941); Nausea (1970); Test Result (2695); No Code Available (3191)

Event Type  No Answer Provided  

Event Description

Tumor on ovary [ovarian neoplasm], kidney stones [renal stone], dry mouth [dry mouth], dry lips[dry lips], cracked lips[cracked lips], skin around mouth dry[dry skin], aftertaste [aftertaste], nauseous [nausea], stomach problem [gastric disorder], sick [sickness], possible allergy [allergy], irritation (nos) [ill-defined disorder], digestive problem [digestion impaired], diarrhea [diarrhea], kidney problem [renal disorder], bacterial infection [bacterial infection], elevated liver enzymes or test [elevated liver enzymes], device misuse [device misuse].Case description: this case reported by a consumer and described the occurrence of ovarian neoplasm in a (b)(6) female patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number tp15207, expiry date unk) for denture wearer.Additional patient notes included consumer reported that she has a history of digestive problems.On an unk date, the patient started super poligrip original (zinc free formula).On an unk date an unk time after starting super poligrip original (zinc free formula), the patient experienced ovarian neoplasm (serious criteria gsk medically significant), renal stone (serious criteria gsk medically significant), dry mouth, lip dry, cracked lips, dry skin, after taste, nausea, gastric disorder, sickness, allergy, ill-defined disorder, digestion impaired, diarrhea, renal disorder, bacterial infection, elevated liver enzymes and device misuse.Super poligrip original (zinc free formula) was continued with no change.On an unk date, the out of the ovarian neoplasm, renal stone, dry mouth, lip dry, cracked lips, dry skin, after taste, nausea, gastric disorder, sickness, allergy, ill-defined disorder, digestion impaired, diarrhea, renal disorder, bacterial infection and elevated liver enzymes were not recovered/not resolved and the outcome of the device misuse was unk.It was unk if the reporter considered the ovarian neoplasm, renal stone, dry mouth, lip dry, cracked lips, dry skin, after taste, nausea, gastric disorder, sickness, allergy, ill-defined disorder, digestion impaired, diarrhea, renal disorder, bacterial infection and elevated liver enzymes to be related to super poligrip original (zinc free formula).Additional details: consumer started using super poligrip original in (b)(6) 2014.She reported that she experienced dry mouth, dry lips, cracked lips and dry skin around her mouth, nausea, difficult digestion, gastric problems further described as stomach issues, sick, possible allergy, irritation, diarrhea and aftertaste.Consumer reported renal problems further described as kidney issues.Consumer reported that she was seen by a healthcare professional in the emergency room and was told that she had and a bacterial infection in her intestine, kidneys and liver.While in the emergency room, she had testing done.She was reported that the testing showed that she had kidney stone, elevated liver enzymes and an ovarian neoplasm.Consumer is still experiencing these events and is still using the product.Consumer reported that she called poison control and they advised her about ethanol in the product being a laxative.Consumer reported that she has a doctor's appointment in (b)(6) 2015.Consumer reported device misuse of she sometimes uses more than what is directed on the back on the box.F/u info was received on 02/13/2015 and an ae revision was make on (b)(6) 2015.The updated info is included in the above narrative.

• Brand Name: SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA),
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GSK DUNGARCAN STAFFORD MILLER; dungarvan, ; EI
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; rtp, NC 27709 ; 8888255249
• MDR Report Key: 4534011
• MDR Text Key: 5513137
• Report Number: 9681138-2015-00006
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: TP15207
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR