MAUDE Adverse Event Report: GLAXOSMITHKLINE SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM; TRIPLE SALT DENTAL ADHESIVE CREAM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); Pain (1994); Tingling (2171); Toxicity (2333); Disability (2371); Numbness (2415); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Type  Other  

Event Description

This case was reported by a consumer and described the occurence of zinc poisoning in a female patient who received triple salt dental adhesive cream (super poligrip original denture adhesive cream) for denture adhesion.A physician or other health care professional has not verified this report.The patient's past medical history included back surgery (2006) and tooth extraction (2004).Concurrent medical conditions included dentures and fibromyalgia.On an unknown date, the patient started triple salt dental adhesive cream.At an unknown time after starting triple salt dental adhesive cream, the patient experienced zinc poisoning, decreased mobility, walking difficulty, numb feet, numbness in hand, numbness in finger, tingling of extremity, tingling hands feet, mental disorder, muscle pain, bone pain, pain, back pain, foot pain, hand pain, leg pain, mouth pain and nausea.This case was assessed as medically serious by gsk.The patient was treated with promethazine hydrochloride (phenergan) and pain medication.Treatment with triple salt dental adhesive cream was continued, per the patient.At the time of reporting, the events were unresolved.(note: super poligrip original was reformulated in 2010 to a double salt formulation (did not contain zinc).It is unknown whether the consumer continued to use the triple salt formulation or a double salt formulation.Consumer reported that she began using super poligrip original with zinc in 2004 and is (b)(6) now.Consumer reported that she used the super poligrip original with zinc and experienced nausea, tingling in her hands and tingling in her feet.Consumer also reported numbness in her feet, numbness in her hand and numbness in her fingers.Consumer reported having difficulty walking further described as having to use a walker or cane to get around.Consumer reported that she has decreased mobility further described as being unable to sweep or vacuum her own floor.Consumer reported that she has pain further described as having a lot of pain.Consumer reported pain in her back, pain in her mouth, pain in her leg, pain in her feet and pain in her hands.Consumer reported her muscles hurting and her bones hurting.Consumer also reported mental disorder further described as it affected her mind.Consumer reported that she has zinc poisoning.Consumer stated that she is still experiencing all events and is currently using the product.Consumer unable to provide lot code.Consumer unable to provide additional product information.Consumer stated that she may get her medical records and contact her lawyer.Super poligrip with zinc was manufactured in (b)(4), and neither the product nor the lot number for this product is available.(b)(4).

• Brand Name: SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM
• Type of Device: TRIPLE SALT DENTAL ADHESIVE CREAM
• Manufacturer (Section D): GLAXOSMITHKLINE; research triangle park NC 27709
• Manufacturer (Section G): GLAXOSMITHKLINE; youghal rd.; clocherane, dungarvan ; EI
• Manufacturer Contact: p.o. box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4096742
• MDR Text Key: 20125767
• Report Number: 9681138-2014-00020
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• 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