MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

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Lot Number R44750

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/02/2020

Event Type Injury

Event Description

Patient experienced wound with a size of a 20 cent coin [wound].Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received thermacare heatwrap (thermacare menstrual), from (b)(6) 2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced a wound with a size of a 20 cent coin on (b)(6) 2020.The action taken in response to the event for thermacare heatwrap and event outcome were 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 "wound" 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 "wound" 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.

Manufacturer Narrative

Event Description

Burn with a size of a 20 cent coin/ opened burn blister/ burn wound [burns second degree], expiry date was 31aug2019 [expired device used].Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received thermacare heatwrap (thermacare menstrual), lot#: r44750, expiration date: 31aug2019, from 02jan2020 to 04jan2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced a wound with a size of a 20 cent coin on (b)(6) 2020, later described as a "burn wound with a size of a 2 cent coin with opened burn blister." treatment for burn with burn blister included wound and burn gel (from wala), and sterile bandage.The action taken in response to the events for thermacare heatwrap and events outcome were unknown.The sample was not available.According to product quality complaint group on (b)(6) 2020: conclusion for the complaint "burn": 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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.According to product quality complaint group on (b)(6) 2020: severity of harm was provided as s3.Conclusion for the complaint "a wound with a size of a 20 cent coin": 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 experiencing "a wound with a size of a 20 cent coin." the cause of a "a wound with a size of a 20 cent coin" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Follow-up (17jan2020 and 22jan2020): new information received from local pqc included: lot number received and sample is not available.Follow-up (30jan2020 and 17feb2020): new information received from the product quality complaint group on 30jan2020 included: suspect product data (expiration date), new event (burn, expiry date was aug2019), and investigation results.New information received from the same pharmacist on 17feb2020 included: updated event (burn blister).Follow-up (17feb2020): new information received from contactable pharmacist includes: additional event description and treatment details.Additionally, this follow-up is being submitted to amend previously reported information: updated reporting criteria (to "unanticipated serious deterioration in state of health").Follow-up (20mar2020): new information received from the product quality complaint group included: updated investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the complaint of "burn blister" and expired device used as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and 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.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions is suggested at this time.

Event Description

Patient experienced wound with a size of a 20 cent coin [wound].Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received thermacare heatwrap (thermacare menstrual), lot # r44750, expiration date not provided, from 02jan2020 to 04jan2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced a wound with a size of a 20 cent coin on (b)(6) 2020.The action taken in response to the event for thermacare heatwrap and event outcome were unknown.The sample was not available.Additional information has been requested and will be provided as it becomes available.Follow-up (17jan2020 and 22jan2020): new information received from local pqc included: lot number received and sample is not available.Company clinical evaluation comment: based on the information provided, the event of "wound" 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., comment: based on the information provided, the event of "wound" 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.

Manufacturer Narrative

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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.

Event Description

Event verbatim [preferred term] burn with a size of a 20 cent coin/ burn blister [burns second degree] , expiry date was (b)(6) 2019 [expired device used] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received thermacare heatwrap (thermacare menstrual), lot # r44750, expiration date (b)(6) 2019, from (b)(6) 2020 to (b)(6) 2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient got a burn.The patient experienced a wound with a size of a 20 cent coin on (b)(6) 2020.The patient's wound was a burn with burn blister.The action taken in response to the events for thermacare heatwrap and events outcome were unknown.The sample was not available.According to product quality complaint group: conclusion: 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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2020 and (b)(6) 2020): new information received from local pqc included: lot number received and sample is not available.Follow-up ((b)(6) 2020 and (b)(6) 2020): new information received from the product quality complaint group on 30jan2020 included: suspect product data (expiration date), new event (burn, expiry date was aug2019), and investigation results.New information received from the same pharmacist on (b)(6) 2020 included: updated event (burn blister).Company clinical evaluation comment: based on the information provided, the complaint of "burn blister" and expired device used as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.This case will be re-assessed should additional information becomes available., comment: based on the information provided, the complaint of "burn blister" and expired device used as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.This case will be re-assessed should additional information becomes available.

Event Description

Event verbatim [preferred term] burn with a size of a 20 cent coin/ opened burn blister/ burn wound [burns second degree] , expiry date was 31aug2019 [expired device used] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received thermacare heatwrap (thermacare menstrual), lot # r44750, expiration date 31aug2019, from 02jan2020 to 04jan2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced a wound with a size of a 20 cent coin on (b)(6) 2020, later descriped as a "burn wound with a size of a 2 cent coin with opened burn blister." treatment for burn with burn blister included wound and burn gel (from wala), and sterile bandage.The action taken in response to the events for thermacare heatwrap and events outcome were unknown.The sample was not available.According to product quality complaint group: conclusion: 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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Follow-up (17jan2020 and 22jan2020): new information received from local pqc included: lot number received and sample is not available.Follow-up (30jan2020 and 17feb2020): new information received from the product quality complaint group on 30jan2020 included: suspect product data (expiration date), new event (burn, expiry date was aug2019), and investigation results.New information received from the same pharmacist on 17feb2020 included: updated event (burn blister).Follow-up (17feb2020): new information received from contactable pharmacist includes: additional event description and treatment details.Additionally, this follow-up is being submitted to amend previously reported information: updated reporting criteria (to "unanticipated serious deterioration in state of health").Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the complaint of "burn blister" and expired device used as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.This case will be re-assessed should additional information becomes available., comment: based on the information provided, the complaint of "burn blister" and expired device used as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and events cannot be ruled out.This case will be re-assessed should additional information becomes available.

Manufacturer Narrative

Event Description

Event verbatim [preferred term].Burn with a size of a 20 cent coin/ opened burn blister/ burn wound [burns second degree], expiry date was 31aug2019 [expired device used].Narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received thermacare heatwrap (thermacare menstrual), lot # r44750, expiration date 31aug2019, from 02jan2020 to 04jan2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced a wound with a size of a 20 cent coin on (b)(6) 2020, later described as a "burn wound with a size of a 2 cent coin with opened burn blister." treatment for burn with burn blister included wound and burn gel (from wala), and sterile bandage.The action taken in response to the events for thermacare heatwrap and events outcome were unknown.The sample was not available.According to product quality complaint group on (b)(6) 2020: conclusion for the complaint "burn": 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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.According to product quality complaint group on (b)(6) 2020: severity of harm was provided as s3.Conclusion for the complaint "a wound with a size of a 20 cent coin": 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 experiencing "a wound with a size of a 20 cent coin." the cause of a "a wound with a size of a 20 cent coin" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.According to product quality complaints on (b)(6) 2020: batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing root cause related to the complaint.Per (b)(4), complaint trending guideline, effective (b)(6) 2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment adverse event safety request for investigation (b)(4).On the basis of this evaluation, a trend does not exist for this batch.The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blisters".The cause of the "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Follow-up (17jan2020 and 22jan2020): new information received from local pqc included: lot number received and sample is not available.Follow-up (30jan2020 and 17feb2020): new information received from the product quality complaint group on 30jan2020 included: suspect product data (expiration date), new event (burn, expiry date was (b)(6) 2019), and investigation results.New information received from the same pharmacist on 17feb2020 included: updated event (burn blister).Follow-up (17feb2020): new information received from contactable pharmacist includes: additional event description and treatment details.Additionally, this follow-up is being submitted to amend previously reported information: updated reporting criteria (to "unanticipated serious deterioration in state of health").Follow-up (20mar2020): new information received from the product quality complaint group included: updated investigation results.Follow-up (25mar2020): new information received from a product quality complaint group includes investigation results.No follow-up attempts are possible.No further information is expected., comment: based on the information provided, the complaint of "burn blister" and expired device used as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and 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.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions is suggested at this time.

Manufacturer Narrative

Conclusion for the complaint "burn": 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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.According to product quality complaint group on 20mar2020: severity of harm was provided as s3.Conclusion for the complaint "a wound with a size of a 20 cent coin": 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 experiencing "a wound with a size of a 20 cent coin." the cause of a "a wound with a size of a 20 cent coin" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Summary of investigations: batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Exped trend assessment & rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36 month trending chart attachment adverse event serious unknown menstrual 8hr 17-jan-2017 to 17-jan-2020.No further action required.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.According to product quality complaints on 25mar2020: batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing root cause related to the complaint.Per sop-105746, complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment adverse event safety request for investigation r44750.On the basis of this evaluation, a trend does not exist for this batch.The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blisters".The cause of the "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.

Event Description

Event verbatim [preferred term] expiry date was 31aug2019 [expired device used], burn with a size of a 20 cent coin/ opened burn blister/ burn wound [burns second degree], , narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received thermacare heatwrap (thermacare menstrual), lot # r44750, expiration date 31aug2019, from 02jan2020 to 04jan2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced a wound with a size of a 20 cent coin on 02jan2020, later described as a "burn wound with a size of a 2 cent coin with opened burn blister." treatment for burn with burn blister included wound and burn gel (from wala), and sterile bandage.The action taken in response to the events for thermacare heatwrap and events outcome were unknown.The sample was not available.According to product quality complaint group on 30jan2020: conclusion for the complaint "burn": 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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.According to product quality complaint group on 20mar2020: severity of harm was provided as s3.Conclusion for the complaint "a wound with a size of a 20 cent coin": 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 experiencing "a wound with a size of a 20 cent coin." the cause of a "a wound with a size of a 20 cent coin" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Summary of investigations: batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Exped trend assessment & rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36 month trending chart attachment adverse event serious unknown menstrual 8hr 17-jan-2017 to 17-jan-2020.No further action required.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.According to product quality complaints on 25mar2020: batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing root cause related to the complaint.Per sop-105746, complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment adverse event safety request for investigation r44750.On the basis of this evaluation, a trend does not exist for this batch.The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blisters".The cause of the "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Follow-up (17jan2020 and 22jan2020): new information received from local pqc included: lot number received and sample is not available.Follow-up (30jan2020 and 17feb2020): new information received from the product quality complaint group on 30jan2020 included: suspect product data (expiration date), new event (burn, expiry date was aug2019), and investigation results.New information received from the same pharmacist on 17feb2020 included: updated event (burn blister).Follow-up (17feb2020): new information received from contactable pharmacist includes: additional event description and treatment details.Additionally, this follow-up is being submitted to amend previously reported information: updated reporting criteria (to "unanticipated serious deterioration in state of health") follow-up (20mar2020): new information received from the product quality complaint group included: updated investigation results.Follow-up (25mar2020): new information received from a product quality complaint group includes investigation results.No follow-up attempts are possible.No further information is expected.Follow-up (13oct2020): new information received from a product quality complaint group includes updated trend information., comment: based on the information provided, the complaint of "burn blister" and expired device used as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and 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.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions is suggested at this time.

Event Description

Event verbatim [preferred term] expiry date was 31aug2019 [expired device used], burn with a size of a 20 cent coin/ opened burn blister/ burn wound [burns second degree], , narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received thermacare heatwrap (thermacare menstrual), lot # r44750, expiration date 31aug2019, from 02jan2020 to 04jan2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced a wound with a size of a 20 cent coin on 02jan2020, later described as a "burn wound with a size of a 2 cent coin with opened burn blister." treatment for burn with burn blister included wound and burn gel (from wala), and sterile bandage.The action taken in response to the events for thermacare heatwrap and events outcome were unknown.The sample was not available.According to product quality complaint group on 30jan2020: conclusion for the complaint "burn": 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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.According to product quality complaints on 25mar2020: batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blisters".The cause of the "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.According to product quality complaint group on 27oct2020: conclusion for the complaint "a wound with a size of a 20 cent coin": 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 experiencing "a wound with a size of a 20 cent coin." the cause of a "a wound with a size of a 20 cent coin" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.The product expired 31-aug-2019.The product quality for the batch is not impacted by this complaint.Summary of investigations: batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment & rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36 month trending chart attachment adverse event serious unknown menstrual 8hr 17-jan-2017 to 17-jan-2020.No further action required.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.Severity of harm was provided as s3.Site sample status was not received.Follow-up (17jan2020 and 22jan2020): new information received from local pqc included: lot number received and sample is not available.Follow-up (30jan2020 and 17feb2020): new information received from the product quality complaint group on 30jan2020 included: suspect product data (expiration date), new event (burn, expiry date was aug2019), and investigation results.New information received from the same pharmacist on 17feb2020 included: updated event (burn blister).Follow-up (17feb2020): new information received from contactable pharmacist includes: additional event description and treatment details.Additionally, this follow-up is being submitted to amend previously reported information: updated reporting criteria (to "unanticipated serious deterioration in state of health") follow-up (20mar2020): new information received from the product quality complaint group included: updated investigation results.Follow-up (25mar2020): new information received from a product quality complaint group includes investigation results.No follow-up attempts are possible.No further information is expected.Follow-up (13oct2020): new information received from a product quality complaint group includes updated trend information.Follow-up (27oct2020): new information received from the product quality complaint group includes updated investigational results.

Manufacturer Narrative

Conclusion for the complaint "burn": 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 "a burn".The cause of the "burn" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blisters".The cause of the "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Conclusion for the complaint "a wound with a size of a 20 cent coin": 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 experiencing "a wound with a size of a 20 cent coin." the cause of a "a wound with a size of a 20 cent coin" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.The product expired 31-aug-2019.The product quality for the batch is not impacted by this complaint.Summary of investigations: batch r44750 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment & rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36 month trending chart attachment adverse event serious unknown menstrual 8hr (b)(6) 2017 to (b)(6)2020.No further action required.There was deviation from sop-105746, complaint trending guidelines, effective (b)(6)2020 in which the expedite trending of complaint investigations was trended for a month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr(b)(6), action item pr(b)(6).Severity of harm was provided as s3.Site sample status was not received.

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Brand Name

THERMACARE MENSTRUAL

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

9604000

MDR Text Key

189160922

Report Number

1066015-2020-00008

Device Sequence Number

Product Code

IMD

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

foreign,health professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Lay User/Patient

Device Expiration Date

08/31/2019

Device Lot Number

R44750

Was Device Available for Evaluation?

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

01/17/2020

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided

Supplement Dates FDA Received

02/04/2020
02/24/2020
03/10/2020
04/03/2020
09/18/2020
10/21/2020
10/30/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

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