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| Lot Number T73713 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Swelling (2091); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Event Description
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Burn blister [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer via medical information team.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced a burn blister after using one of thermacare heatwraps on an unspecified date.She has been using products for years and that was the first time! the action taken in response to the event for thermacare heatwrap and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] burn blister [burns second degree] , slight burn scarring [scar] ,.Case narrative:this is a spontaneous report from a contactable consumer via medical information team.A 53-yeay-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: t73713, expiration date: aug2020) via an unspecified route of administration for years at an unspecified dose for muscle tension.The patient medical history included post-menopausal, diabetes, circulatory disorder, sensitive skin and skin disease.She was currently under the care of a physician for known (for 10 years) disease.Consumer reported her skin tone was medium.Consumer was not pregnant.Consumer took concomitant medication (unspecified) during use of thermacare, also during previous applications.The consumer had previously used thermacare heatwrap and did not experience the event burn blister.The consumer had also previously used other heat products for pain relief on 2017, for 1-2 months, without problem/symptom.The patient experienced a burn blister after using one of thermacare heatwraps on an unspecified date.She has been using products for years and that was the first time.Patient reported she was sleeping while wearing the product; she was wearing only a cotton nightdress over the thermacare product and she attached the adhesive to body.Consumer reported she checked her skin under the product while wearing for two times.She also reported she read the usage instructions on thermacare before using the product.She did not engage in exercise while using the product (for example, running, bicycling).She used the wrap for 5 hours that day.Consumer reported she had no hospitalization, she did not consult a healthcare professional for the problem and no treatment was needed for burn blister.Consumer is well again.Therapy with thermacare heatwrap was withdrawn on feb2020 in response to the event.The outcome of the event the event burn blister was resolved with sequel at the time of the report: slight burn scarring was present (not recovered).According to product quality complaint group: the severity of harm has been selected by the manufacturing site as s3 and the record needs to be assessed by pfizer safety for mdr reporting.Reasonably suggest device malfunction was yes.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.Follow-up attempts are completed.No further information is expected.Follow-up (23jan2020): new information received from product quality complaint group includes severity of harm.Follow-up (04feb2020): new information received from pfizer product quality group included: investigation results.Follow-up (17feb2020): new information received from the contactable consumer includes: consumer's demographics provided, medical history, thermacare heatwrap specified as thermacare neck, shoulder & wrist, indication, lot number and expiration date, action taken, stop date, event outcome (slight burn scarring reported as sequel), concomitant medication., comment: based on the information provided, the event of "burn blisters with slight burn scarring" 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 suspect device and the events cannot be ruled out.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.There is not a product quality related trend identified.No further investigations or actions is suggested at this time.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.
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Event Description
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Event verbatim [preferred term] burn blister [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer via medical information team.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced a burn blister after using one of thermacare heatwraps on an unspecified date.She has been using products for years and that was the first time! the action taken in response to the event for thermacare heatwrap and event outcome was unknown.The severity of harm has been selected by the manufacturing site as s3 and the record needs to be assessed by pfizer safety for mdr reporting.Reasonably suggest device malfunction was yes.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Follow-up (23jan2020): new information received from product quality complaint group includes severity of harm.Comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term]: burn blister [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer via medical information team.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration for years at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced a burn blister after using one of thermacare heatwraps on an unspecified date.She has been using products for years and that was the first time! the action taken in response to the event for thermacare heatwrap and event outcome was unknown.According to product quality complaint group: the severity of harm has been selected by the manufacturing site as s3 and the record needs to be assessed by pfizer safety for mdr reporting.Reasonably suggest device malfunction was yes.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.Follow-up (23jan2020): new information received from product quality complaint group includes severity of harm.Follow-up (04feb2020): new information received from pfizer product quality group included: investigation results.Company clinical evaluation comment based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.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.There is not a product quality related trend identified.No further investigations or actions is suggested at this time., comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.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.There is not a product quality related trend identified.No further investigations or actions is suggested at this time.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.
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Event Description
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Event verbatim [preferred term]: burn blister [burns second degree], slight burn scarring [scar].Case narrative:this is a spontaneous report from a contactable consumer via medical information team.A 52-yeay-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: t73713, expiration date: aug2020) via an unspecified route of administration for years at an unspecified dose for muscle tension.The patient medical history included post-menopausal, diabetes, circulatory disorder, sensitive skin and skin disease.She was currently under the care of a physician for known (for 10 years) disease.Consumer reported her skin tone was medium.Consumer was not pregnant.Consumer took concomitant medication (unspecified) during use of thermacare, also during previous applications.The consumer had previously used thermacare heatwrap and did not experience the event burn blister.The consumer had also previously used other heat products for pain relief on 2017, for 1-2 months, without problem/symptom.The patient experienced a burn blister after using one of thermacare heatwraps on an unspecified date.She has been using products for years and that was the first time.Patient reported she was sleeping while wearing the product; she was wearing only a cotton nightdress over the thermacare product and she attached the adhesive to body.Consumer reported she checked her skin under the product while wearing for two times.She also reported she read the usage instructions on thermacare before using the product.She did not engage in exercise while using the product (for example, running, bicycling).She used the wrap for 5 hours that day.Consumer reported she had no hospitalization, she did not consult a healthcare professional for the problem and no treatment was needed for burn blister.Consumer is well again.Therapy with thermacare heatwrap was withdrawn on (b)(6) 2020 in response to the event.The outcome of the event the event burn blister was resolved with sequel at the time of the report: slight burn scarring was present (not recovered).According to product quality complaint group: the severity of harm has been selected by the manufacturing site as s3 and the record needs to be assessed by pfizer safety for mdr reporting.Reasonably suggest device malfunction was yes.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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.Follow-up attempts are completed.No further information is expected.Follow-up (23jan2020): new information received from product quality complaint group includes severity of harm.Follow-up (04feb2020): new information received from pfizer product quality group included: investigation results.Follow-up (17feb2020): new information received from the contactable consumer includes: consumer's demographics provided, medical history, thermacare heatwrap specified as thermacare neck, shoulder & wrist, indication, lot number and expiration date, action taken, stop date, event outcome (slight burn scarring reported as sequel), concomitant medication.Amendment: the follow-up report is being submitted to amend previously reported information: the patient was 52-year-old., comment: based on the information provided, the event of "burn blisters with slight burn scarring" 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 suspect device and the events cannot be ruled out.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.There is not a product quality related trend identified.No further investigations or actions is suggested at this time.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn and blister".The cause of the consumer stating the wrap caused a burn and blister is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Site sample status was not received.
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Event Description
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Event verbatim [preferred term] burn blister [burns second degree], slight burn scarring [scar].Case narrative:this is a spontaneous report from a contactable consumer via medical information team.A 52-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: t73713, expiration date: aug2020) via an unspecified route of administration for years at an unspecified dose for muscle tension.The patient medical history included post-menopausal, ongoing diabetes, circulatory disorder, sensitive skin and skin disease.She was currently under the care of a physician for known (for 10 years) disease.Consumer reported her skin tone was medium.Consumer was not pregnant.Consumer took concomitant medication (unspecified) during use of thermacare, also during previous applications.The consumer had previously used thermacare heatwrap and did not experience the event burn blister.The consumer had also previously used other heat products for pain relief in 2017, for 1-2 months, without problem/symptom.The patient experienced a burn blister after using one of thermacare heatwraps and slight burn scarring was present on an unspecified date when she was 52 years old.She used the wrap for 5 hours that day.The patient had been using products for years and that was the first time.Patient reported she was sleeping while wearing the product; she was wearing only a cotton nightdress over the thermacare product and she attached the adhesive to body.Consumer reported she checked her skin under the product while wearing for two times.She also reported she read the usage instructions on thermacare before using the product.She did not engage in exercise while using the product (for example, running, bicycling).Consumer reported she had no hospitalization, she did not consult a healthcare professional for the problem and no treatment was needed for burn blister.Consumer was well again.There was no product remaining.Therapy with thermacare heatwrap was withdrawn in (b)(6) 2020 in response to the event.The outcome of the event burn blister was resolved with sequel, of the event slight burn scarring was not recovered.According to product quality complaint group: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn and blister".The cause of the consumer stating the wrap caused a burn and blister is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Site sample status was not received.Follow-up (23jan2020): new information received from product quality complaint group includes severity of harm.Follow-up (04feb2020): new information received from pfizer product quality group included: investigation results.Follow-up (17feb2020): new information received from the contactable consumer includes: consumer's demographics provided, medical history, thermacare heatwrap specified as thermacare neck, shoulder & wrist, indication, lot number and expiration date, action taken, stop date, event outcome (slight burn scarring reported as sequel), concomitant medication.Amendment: the follow-up report is being submitted to amend previously reported information: the patient was 52-year-old.Follow up (20mar2020): new information received from product quality complaint group included: updated investigation result.Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the event of "burn blisters with slight burn scarring" 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 suspect device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.
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Event Description
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Event verbatim [preferred term], burn blister [burns second degree], slight burn scarring [scar], narrative: this is a spontaneous report from a contactable consumer via medical information team.A 52-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: t73713, expiration date: aug2020) via an unspecified route of administration for years at an unspecified dose for muscle tension.The patient medical history included ongoing post-menopausal, ongoing diabetes, circulatory disorder, sensitive skin and skin disease.She was currently under the care of a physician for known (for 10 years) disease.Consumer reported her skin tone was medium.Consumer was not pregnant.Consumer took concomitant medication (unspecified) during use of thermacare, also during previous applications.The consumer had previously used thermacare heatwrap and did not experience the event burn blister.The consumer had also previously used other heat products for pain relief in 2017, for 1-2 months, without problem/symptom.The patient experienced a burn blister after using one of thermacare heatwraps and slight burn scarring was present on an unspecified date when she was 52 years old.She used the wrap for 5 hours that day.The patient had been using products for years and that was the first time.Patient reported she was sleeping while wearing the product; she was wearing only a cotton nightdress over the thermacare product and she attached the adhesive to body.Consumer reported she checked her skin under the product while wearing for two times.She also reported she read the usage instructions on thermacare before using the product.She did not engage in exercise while using the product (for example, running, bicycling).Consumer reported she had no hospitalization, she did not consult a healthcare professional for the problem and no treatment was needed for burn blister.Consumer was well again.There was no product remaining.Therapy with thermacare heatwrap was withdrawn in (b)(6) 2020 in response to the event.The outcome of the event burn blister was resolved with sequel, of the event slight burn scarring was not recovered.According to product quality complaint group: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn and blister".The cause of the consumer stating the wrap caused a burn and blister is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Site sample status was not received.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend actions taken: this investigation was reopened on 07-oct-2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-105746, complaint trending guidelines, effective dates (b)(6) 2019 and (b)(6) 2020.A notification of nonconformance was opened pr-(b)(4).This deviation will not change the conclusion of the investigation.Follow-up (23jan2020): new information received from product quality complaint group includes severity of harm.Follow-up (04feb2020): new information received from pfizer product quality group included: investigation results.Follow-up (17feb2020): new information received from the contactable consumer includes: consumer's demographics provided, medical history, thermacare heatwrap specified as thermacare neck, shoulder & wrist, indication, lot number and expiration date, action taken, stop date, event outcome (slight burn scarring reported as sequel), concomitant medication.Amendment: the follow-up report is being submitted to amend previously reported information: the patient was 52-year-old.Follow up (20mar2020): new information received from product quality complaint group included: updated investigation result.Follow-up attempts are completed.No further information is expected.Follow-up (12oct2020): new information received from product quality complaint group included: updated trending information.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of "burn blisters with slight burn scarring" 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 suspect device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn and blister".The cause of the consumer stating the wrap caused a burn and blister is inconclusive since review of records does not provide evidence to support defective product.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Site sample status was not received.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend actions taken: this investigation was reopened on 07-oct-2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-105746, complaint trending guidelines, effective dates 19-nov-2019 and 24-feb-2020.A notification of nonconformance was opened pr-(b)(4).This deviation will not change the conclusion of the investigation.
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Search Alerts/Recalls
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