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U.S. Department of Health and Human Services

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

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BLAXOSMITH KLINE SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM; TRIPLE SALT DENTAL ADHESIVE CREAM Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Device Operates Differently Than Expected (2913)
Patient Problems Anemia (1706); Death (1802); Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)
Event Type  Death  
Event Description
This case was reported by a consumer and described the occurrence of death nos in a (b)(6) year-old male pt who received triple salt dental adhesive cream (super poligrip original denture adhesive cream) cream for dentures.A physician or other health care professional has not verified this report.Co-suspected medication included polident.Concurrent medications included blood pressure medication and unk (unk medication).On an unk date, the pt started triple salt dental adhesive cream (dental) and polident.At an unk time after starting triple salt dental adhesive cream and polident, the pt experienced death nos, multiple myeloma, neuropathy, foot pain, tingling feet, numb feet, walking difficulty, poor balance, anemia and drug maladministration.The pt's wife reported that her husband had used super poligrip with zinc in it for a few years.She reported her husband excessively used the super poligrip (drug maladministration) to hold a plate that did not fit per his dentist orders.She stated that her husband had a plate that had hooks on it that fit into the jaw.She stated that it did not hold and would not work so the dentist's only recommendation was to use a lot of super poligrip.She state that he used so much of the product that it took him an hour to get it off of his plate at the end of the day.She reported that her husband was diagnosed with multiple myeloma in 2005.She described multiple myeloma as a rare cancer that affected bone marrow of the bones.She stated that he was also diagnosed with neuropathy around the same time.She reported that her husband had pain, tingling and numbness in his feet.She stated that he had difficulty walking and poor balance.She reported that he also had anemia.She reported that her husband was in and out of the hospital several times before he went to (b)(6) where he passed away in 2008.She reported that he saw a neurologist and a cancer doctor.She stated that she was not certain if her husband's cancer doctor knew that he was using super poligrip or of the way he was using it.She stated that none of the doctors could tell them what had caused her husband's problems.She stated that the doctors kept saying he got into something he should not have ever been into, something environmental.She reported that her husband refused a treatment medication called revlimid because he was told it could make his neuropathy worse.She reported that she read in the newspaper that the zinc in super poligrip could cause blood problems which is why she called.She reported that her husband also used polident and read that it could cause blood problems.She is concerned that something in polident and super poligrip may have lead to her husband's death.The pt died in 2008 from death nos.It is unk whether an autopsy was performed.The manufacturer's report numbers for this case are super poligrip original denture adhesive cream (9681138-2014-00001) and polident (1020379-2014-00001).Super poligrip original denture adhesive cream is manufactured in (b)(4) and polident is manufactured in (b)(4).Neither the products nor lot numbers for these products are available.
 
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Brand Name
SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM
Type of Device
TRIPLE SALT DENTAL ADHESIVE CREAM
Manufacturer (Section D)
BLAXOSMITH KLINE
research triangle park NC 27709
Manufacturer (Section G)
GLAXOSMITHKLINE
youghal road
clocherane, dungarvan
EI  
Manufacturer Contact
po box 13398
research triangle park, NC 27709
8888255249
MDR Report Key3594390
MDR Text Key16013554
Report Number9681138-2014-00001
Device Sequence Number1
Product Code KOL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Type of Report Initial
Report Date 01/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 01/16/2014
Initial Date FDA Received01/22/2014
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 Number1
Treatment
UNK MEDICATION; BLOOD PRESSURE MEDICATION
Patient Outcome(s) Death;
Patient Age75 YR
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