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| Device Problem
Expiration Date Error (2528)
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| Patient Problem
Death (1802)
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| Event Date 02/01/2019 |
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Event Type
Death
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Event Description
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Using it but he died a month ago [death].Case narrative: this is a spontaneous report from a non-contactable consumer reporting for her husband.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), expiration date nov2006, from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer would like to know where to find the expiration date on the box and wrap of the thermacare lower back.She stated that her husband was using it but he died a month ago, in (b)(6) 2019.Agent helped the consumer locate the expiration date per sample on the floor.The expiration date is nov2006.Action taken in response to the event was unknown.The patient died on an unspecified date in (b)(6) 2019.It was not reported if an autopsy was performed.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: there is very limited information with regard to the cause of the death of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported death (unknown cause) at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.This case will be re-assessed when additional information becomes available.
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Event Description
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Event verbatim [preferred term] using it but he died a month ago [death] ,.Case narrative:this is a spontaneous report from a non-contactable consumer reporting for her husband.A male patient of unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), expiration date nov2006, from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer would like to know where to find the expiration date on the box and wrap of the thermacare lower back.She stated that her husband was using it but he died a month ago, in (b)(6) 2019.Agent helped the consumer locate the expiration date per sample on the floor.The expiration date is nov2006.Action taken in response to the event was unknown.The patient died on an unspecified date in (b)(6) 2019.It was not reported if an autopsy was performed.Conclusion from the product quality complaint group included: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: the pcom search returned a total of (b)(4) complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, (b)(6).There is no further action required.The adverse event safety request for investigation complaint subclass shows an increase in (b)(6) 2018 thru (b)(6) 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug, 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Investigation summary: the root cause category is non-assignable (complaint not confirmed).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event for menstrual products.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (23apr2019): new information received from product quality complaint group include investigational result.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: there is very limited information with regard to the cause of the death of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported death (unknown cause) at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.This case will be re-assessed when additional information becomes available.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.Amendment: this follow-up report is being submitted to amend previously reported information: updated follow up receive date in narrative as 23apr2019.Amendment: this follow-up report is being submitted to amend previously reported information: patient's gender was updated to male., comment: there is very limited information with regard to the cause of the death of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported death (unknown cause) at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.This case will be re-assessed when additional information becomes available.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: the pcom search returned a total of (b)(4) complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, (b)(6).There is no further action required.The adverse event safety request for investigation complaint subclass shows an increase in (b)(6) 2018 thru (b)(6) 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug, 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Investigation summary: the root cause category is non-assignable (complaint not confirmed).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event for menstrual products.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.
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Manufacturer Narrative
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An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: the pcom search returned a total of (b)(4) complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, refer to the attached trend chart for (b)(6) 2016 - (b)(6) 2019.There is no further action required.The adverse event safety request for investigation complaint subclass shows an increase in (b)(6) 2018 thru (b)(6) 2019.This is a seasonality change in combination with a change in safety¿s procedure wsr cp001 wi 110, ¿case processing principles product quality complaint guidance¿, updated on (b)(6) 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Investigation summary: the root cause category is non-assignable (complaint not confirmed).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event for menstrual products.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.
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Event Description
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Event verbatim [preferred term] using it but he died a month ago [death] ,.Case narrative:this is a spontaneous report from a non-contactable consumer reporting for her husband.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), expiration date (b)(6) 2006, from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer would like to know where to find the expiration date on the box and wrap of the thermacare lower back.She stated that her husband was using it but he died a month ago, in (b)(6) 2019.Agent helped the consumer locate the expiration date per sample on the floor.The expiration date is (b)(6) 2006.Action taken in response to the event was unknown.The patient died on an unspecified date in (b)(6) 2019.It was not reported if an autopsy was performed.Conclusion from the product quality complaint group included: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: the pcom search returned a total of (b)(4) complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, refer to the attached trend chart for (b)(6) 2016 - (b)(6) 2019.There is no further action required.The adverse event safety request for investigation complaint subclass shows an increase in (b)(6) 2018 thru (b)(6) 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on 20aug, 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Investigation summary: the root cause category is non-assignable (complaint not confirmed).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event for menstrual products.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (23apr2019): new information received from product quality complaint group include investigational result.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment there is very limited information with regard to the cause of the death of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported death (unknown cause) at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.This case will be re-assessed when additional information becomes available.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.Amendment: this follow-up report is being submitted to amend previously reported information: updated follow up receive date in narrative as 23apr2019., comment: there is very limited information with regard to the cause of the death of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported death (unknown cause) at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.This case will be re-assessed when additional information becomes available.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Event Description
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Event verbatim [preferred term] using it but he died a month ago [death] ,.Case narrative:this is a spontaneous report from a non-contactable consumer reporting for her husband.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), expiration date (b)(6) 2006, from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The consumer would like to know where to find the expiration date on the box and wrap of the thermacare lower back.She stated that her husband was using it but he died a month ago, in (b)(6) 2019.Agent helped the consumer locate the expiration date per sample on the floor.The expiration date is (b)(6) 2006.Action taken in response to the event was unknown.The patient died on an unspecified date in (b)(6) 2019.It was not reported if an autopsy was performed.Conclusion from the product quality complaint group included: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: the pcom search returned a total of (b)(4) complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, refer to the attached trend chart for (b)(6) 2016 - (b)(6) 2019.There is no further action required.The adverse event safety request for investigation complaint subclass shows an increase in (b)(6) 2018 thru (b)(6) 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on (b)(6) aug, 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Investigation summary: the root cause category is non-assignable (complaint not confirmed).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event for menstrual products.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up (23apr2018): new information received from product quality complaint group include investigational result.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment there is very limited information with regard to the cause of the death of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported death (unknown cause) at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.This case will be re-assessed when additional information becomes available.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: there is very limited information with regard to the cause of the death of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported death (unknown cause) at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.This case will be re-assessed when additional information becomes available.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: the pcom search returned a total of (b)(4) complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, refer to the attached trend chart for (b)(6) 2016 - (b)(6) 2019.There is no further action required.The adverse event safety request for investigation complaint subclass shows an increase in nov2018 thru (b)(6) 2019.This is a seasonality change in combination with a change in safety¿s procedure wsr cp001 wi 110, ¿case processing principles product quality complaint guidance¿, updated on 20aug, 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Investigation summary: the root cause category is non-assignable (complaint not confirmed).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event for menstrual products.The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.
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Search Alerts/Recalls
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