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| Device Problem
Loose or Intermittent Connection (1371)
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| Patient Problems
Anemia (1706); Death (1802); Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544); Cancer (3262)
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Event Type
Death
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Event Description
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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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Manufacturer Narrative
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Number 1020379-2014-00001 is associated with argus case (b)(4) polident tablets.
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Event Description
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Neuropathy [neuropathy].Multiple myeloma [multiple myeloma].Foot pain [foot pain].Tingling feet [tingling of extremity].Numb feet, lost feeling in his legs [numbness in feet].Walking difficulty, couldn't walk [walking difficulty].Poor balance [balance difficulty].Anemia [anemia].Fallen [fall].Bone pain [bone pain].When he was in hospice, he had chunks of blood in his mouth [mouth hemorrhage] case description: this case was reported by a consumer and described the occurrence of death nos in a (b)(6) male patient 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-suspect medication included polident.Concurrent medications included blood pressure medication and unknown (unknown medication).On an unknown date, the patient started triple salt dental adhesive cream (dental) and polident.At an unknown time after starting triple salt dental adhesive cream and polident, the patient experienced death nos, multiple myeloma, neuropathy, foot pain, tingling feet, numb feet, walking difficulty, poor balance, anemia and drug maladministration.The patient'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 stated 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 hospice 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 patient died in 2008 from death nos.It is unknown 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 dungarvan, ireland and polident is manufactured in memphis, tennessee.Neither the products nor lot numbers for these products are available.Sae reported via phone (b)(6) 2014: patient's wife reported that her husband had used super poligrip with zinc in it for a few years.Consumer reported drug maladministration with super poligrip because her husband excessively used the product 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 stated that he used so much of the product it took him an hour to get it off on his plate at the end of the day.Consumer reported that her husband was diagnosed with multiple myeloma in 2005.She described that multiple myeloma was 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.Consumer reported that her husband was in and out of the hospital several times before he went to hospice where he had passed away in 2008.She reported that he had seen 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 the doctors kept saying he got into something he should not have ever been into, something environmental.Consumer reported that her husband refused a treatment medication called revlimid because he was told it could make his neuropathy worse.Consumer reported that she had 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.Consumer is concerned if something in polident and super poligrip may have lead to her husband's death.Follow up information was received on (b)(6) 2017.The consumer reported that her husband used super poligrip (variant not specified).Her husband died of neuropathy, he had fallen, could not walk, and died.He also had multiple myeloma, which was a cancer of the blood.He died in (b)(6) 2008.He developed multiple myeloma, and lost feeling in his legs.He had tingling and bone pain.She did not know what specific poligrip he used.He used it to keep his upper plates in place.He was (b)(6) when he died.He had neuropathy as early as 2003.He had been using poligrip since the early 90's, purely to help secure his teeth.He could not take a drug for multiple myeloma because it caused neuropathy.He could had lived a little longer.When he was in hospice, he had chunks of blood in his mouth.Consumer did not have any additional information about the product, or any specific dates for adverse events.Consumer reported that husband has a history of high blood pressure.The patient's current conditions included blood pressure high (taking unspecified blood pressure medication).In 2003, an unknown time after starting super poligrip (unspecified zinc free variant) and polident, the patient experienced neuropathy (serious criteria death).On an unknown date, the patient experienced tingling of extremity, numbness in feet, walking difficulty, balance difficulty, fall, bone pain, mouth hemorrhage and off label use of device.On an unknown date, the outcome of the neuropathy was fatal and the outcome of the tingling of extremity, numbness in feet, walking difficulty, balance difficulty, fall, bone pain, mouth hemorrhage and off label use of device were unknown.The patient died in (b)(6) 2008.The reported cause of death was neuropathy.It was unknown if the reporter considered the neuropathy, tingling of extremity, numbness in feet, walking difficulty, balance difficulty, fall, bone pain and mouth hemorrhage to be related to super poligrip (unspecified zinc free variant) and polident.The suspect product was updated from "super poligrip original denture adhesive cream" to "super poligrip (unspecified zinc free variant)".Concomitant medications included unspecified medication for high blood pressure and unspecified medication.The event of death nos was removed.The event of "drug maladministration" was updated to "off label use of device".
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Manufacturer Narrative
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Argus case id (b)(4).This fu2 report is linked to the fu1 report in argus, as the initial report was submitted under the previous safety database oceans.
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Event Description
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Case description: this case was reported by a consumer and described the occurrence of death nos in a 75-year-old male patient 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-suspect medication included polident.Concurrent medications included blood pressure medication and unknown (unknown medication).On an unknown date, the patient started triple salt dental adhesive cream (dental) and polident.At an unknown time after starting triple salt dental adhesive cream and polident, the patient experienced death nos, multiple myeloma, neuropathy, foot pain, tingling feet, numb feet, walking difficulty, poor balance, anemia and drug maladministration.The patient'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 stated 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 hospice 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 patient died in 2008 from death nos.It is unknown 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 dungarvan, ireland and polident is manufactured in memphis, tennessee.Neither the products nor lot numbers for these products are available.This report is being resubmitted to capture corrections.The information was received on (b)(6) 2017 and is as follows: the product was changed from a double salt dental adhesive cream to a triple salt dental adhesive cream (containing zinc).It was processed correct in initial case.
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Search Alerts/Recalls
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