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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Scarring (2061); Injury (2348); Burn, Thermal (2530)
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Event Type
Injury
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Event Description
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Horrible open burning sores on my abdomen which will more than likely scar/ left me completely burned from one side of my abdomen to the other [thermal burn] ,.Case narrative:this is a spontaneous report from a contactable consumer and from a pfizer sponsored program thermacare (b)(6) page.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), from an unspecified date for menstrual cramps.The patient's medical history and concomitant medications were not reported.The patient experienced horrible open burning sores on my abdomen which will more than likely scar/ left me completely burned from one side of my abdomen to the other on an unspecified date.The patient has used these heat pads for several years and knows how to operate them.The patient can't move without them opening and being raw.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the event of "open burning sores on my abdomen which will more than likely scar/ left me completely burned from one side of my abdomen" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.
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Event Description
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Event verbatim [preferred term].Horrible open burning sores on my abdomen which will more than likely scar/ left me completely burned from one side of my abdomen to the other [thermal burn], , narrative: this is a spontaneous report from a contactable consumer and from a pfizer sponsored program thermacare facebook page.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), from an unspecified date for menstrual cramps.The patient's medical history and concomitant medications were not reported.The patient experienced horrible open burning sores on abdomen which will more than likely scar/ left him/her completely burned from one side of abdomen to the other on an unspecified date.The patient had used these heat pads for several years and knew how to operate them.The patient couldn't move without them opening and being raw.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.Reasonably suggest device malfunction was yes and severity of harm was s3 for sub-class: adverse event/serious/unknown.Follow-up ((b)(6) 2020): follow-up attempts are completed.No further information is expected.Follow up ((b)(6) 2020): new information received from product quality complaints group included: investigation results.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.
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Event Description
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Event verbatim [preferred term].2nd degree burns from one side of abdomen to the other/horrible open burning sores on my abdomen which will more than likely scar/ left me completely burned from one side of my abdomen to the other [burns second degree], giant scars across lower stomach [scar], narrative: this is a spontaneous report from a contactable consumer and from a pfizer sponsored program thermacare facebook page and a pfizer sponsored program pfizer rxpathways.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), from an unspecified date for menstrual cramps/ menstrual pain.The patient's medical history and concomitant medications were not reported.The patient experienced horrible open burning sores on abdomen which will more than likely scar/ left him/her completely burned from one side of abdomen to the other on an unspecified date.The patient had used these heat pads for several years and knew how to operate them.The patient couldn't move without them opening and being raw.During spring of this year, the patient used a thermacare heatwrap for menstrual pain.The patient had used these for years without incident.This time the patient used as directed and suffered 2nd degree burns from one side of abdomen to the other.In addition to medical bills, etc., the patient was now left with giant scars across lower stomach.The action taken with thermacare heatwrap was unknown.The outcome of the event scars across lower stomach was not resolved and for other event was unknown.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.Reasonably suggest device malfunction was yes and severity of harm was s3 for sub-class: adverse event/serious/unknown.Follow-up (23apr2020): follow-up attempts are completed.No further information is expected.Follow up (18may2020): new information received from product quality complaints group included: investigation results.Follow up (20nov2020): new information received from a contactable consumer included: new marketing program name, new events (2nd degree burns from one side of abdomen to the other, giant scars across lower stomach).
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Event Description
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Event verbatim [preferred term]: 2nd degree burns from one side of abdomen to the other/horrible open burning sores on my abdomen which will more than likely scar/ left me completely burned/enormous blisters [burns second degree], giant scars across lower stomach [scar], burns were in fact second & third degree [burns third degree], , narrative: this is a spontaneous report from a contactable consumer and from a pfizer sponsored program thermacare facebook page and a pfizer sponsored program pfizer rxpathways.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), from an unspecified date for menstrual cramps/ menstrual pain.The patient's medical history and concomitant medications were not reported.The patient experienced horrible open burning sores on abdomen which will more than likely scar/ left him/her completely burned from one side of abdomen to the other on an unspecified date.The patient had used these heat pads for several years and knew how to operate them.The patient couldn't move without them opening and being raw.During spring of this year, the patient used a thermacare heatwrap for menstrual pain.The patient had used these for years without incident.This time the patient used as directed and suffered 2nd degree burns from one side of abdomen to the other.In addition to medical bills, etc., the patient was now left with giant scars across lower stomach.The action taken with thermacare heatwrap was unknown.The outcome of the event scars across lower stomach was not resolved and for other event was unknown.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.Reasonably suggest device malfunction was yes and severity of harm was s3 for sub-class: adverse event/serious/unknown.Follow-up (23apr2020): follow-up attempts are completed.No further information is expected.Follow up (18may2020): new information received from product quality complaints group included: investigation results.Follow up (20nov2020): new information received from a contactable consumer included: new marketing program name, new events (2nd degree burns from one side of abdomen to the other, giant scars across lower stomach).Follow-up (25nov2020): this is a spontaneous report from a contactable consumer by way of a letter addressed to the pfizer legal department.The patient had severe and permanent second degree burns he/she suffered after using a thermacare heatwrap for menstrual pain.The patient had been using this product for many years.The patient followed directions to the letter, however this time after removing it he/she realized that he/she had enormous blisters from one side of abdomen to the other.The patient immediately sought medical attention and was advised that these burns were in fact second & third degree (medical records can be provided upon request).It was now months later and the patient had scars across lower abdomen which were not improving whatsoever.Follow-up (09dec2020): according to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products , refer to attachment menstrual 8hr products adverse event serious unknown 17nov2017 to 17nov2020.The sample had not been received by the site.Process related was no.Final confirmation status: not confirmed.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products , refer to attachment menstrual 8hr products adverse event serious unknown 17nov2017 to 17nov2020.The sample had not been received by the site.Process related was no.Final confirmation status: not confirmed.
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Event Description
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Event verbatim [preferred term] 2nd degree burns from one side of abdomen to the other/horrible open burning sores on my abdomen which will more than likely scar/ left me completely burned/enormous blisters [burns second degree], giant scars across lower stomach [scar], burns were in fact second & third degree [burns third degree], , narrative: this is a spontaneous report from a contactable consumer and from a pfizer sponsored program thermacare facebook page and a pfizer sponsored program pfizer rxpathways.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), from an unspecified date for menstrual cramps/ menstrual pain.The patient's medical history and concomitant medications were not reported.The patient experienced horrible open burning sores on abdomen which will more than likely scar/ left him/her completely burned from one side of abdomen to the other on an unspecified date.The patient had used these heat pads for several years and knew how to operate them.The patient couldn't move without them opening and being raw.During spring of this year, the patient used a thermacare heatwrap for menstrual pain.The patient had used these for years without incident.This time the patient used as directed and suffered 2nd degree burns from one side of abdomen to the other.In addition to medical bills, etc., the patient was now left with giant scars across lower stomach.The action taken with thermacare heatwrap was unknown.The outcome of the event scars across lower stomach was not resolved and for other event was unknown.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.Reasonably suggest device malfunction was yes and severity of harm was s3 for sub-class: adverse event/serious/unknown.Follow-up (23apr2020): follow-up attempts are completed.No further information is expected.Follow up (18may2020): new information received from product quality complaints group included: investigation results.Follow up (20nov2020): new information received from a contactable consumer included: new marketing program name, new events (2nd degree burns from one side of abdomen to the other, giant scars across lower stomach).Follow-up (25nov2020): this is a spontaneous report from a contactable consumer by way of a letter addressed to the pfizer legal department.The patient had severe and permanent second degree burns he/she suffered after using a thermacare heatwrap for menstrual pain.The patient had been using this product for many years.The patient followed directions to the letter, however this time after removing it he/she realized that he/she had enormous blisters from one side of abdomen to the other.The patient immediately sought medical attention and was advised that these burns were in fact second & third degree (medical records can be provided upon request).It was now months later and the patient had scars across lower abdomen which were not improving whatsoever.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).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 adverse event/serious/unknown.The 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.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.The sample had not been received by the site.
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Search Alerts/Recalls
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