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 AF0351

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Burn, Thermal (2530)

Event Date 03/29/2019

Event Type Injury

Event Description

Manufacturer Narrative

Initial complaint assessment: batch af0351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 29apr2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defects recorded for the batch.There were two attribute defects recorded for the batch.Twelve glue nozzles were replaced on glue head 02 during production.One dead cell (individual cell pack not dosed with brine solution) was found during production; pump b31 was realigned.Manufacturing personnel performed the corrective action procedure for each event following the sop-54615 ¿production quality control - cap procedure¿ version 4 effective 14dec2015 and form-45377 thermacare corrective action procedure (cap) - individual temperature high/low, version 5 effective 10aug2016.This sop provides instructions to execute equipment trouble shooting when a non-conforming individual cell temperature (cold cell) is observed during the manufacturing process.Pump b31 was found to be out of alignment.The pump was realigned and batch af0351 was completed with no additional oos.The overall thermal data for the batch met the required wrap batch average temperatures (37.6°c to 41.6°c) per menstr.

Event Description

Event verbatim [preferred term] four to five circular burn places on her stomach/caller was burned through first layer to second layer of skin [thermal burn] , they are starting to scab but are painful [scab] , her whole first layer of skin was burned off [skin exfoliation] , the scab comes off and starts to bleed [skin haemorrhage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 38-year-old (no pregnant, no post-menopausal) female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number af0351, expiration date sep2021, udi number(b)(4), on (b)(6) 2019 at 1 patch placed in underwear for 3-4 hours for menstrual cramps.Medical history included crohn's disease and she did not have to go to the physician right now because she was in remission.There were no concomitant medications.The patient previously took thermacare heatwrap (thermacare menstrual) since she was about 14 years old and did not experience any adverse event.The patient bought thermacare patches that she put in her underwear for menstrual cramps.She got 4-5 burn places on her stomach on 29mar2019.She had used the product for years and never had an issue.The burns were circular, like the things inside the pads.She was having a hard time getting the burns to heal.She put on salve and was trying to keep it open to get the burn places to scab over and heal.They were starting to scab but were painful on (b)(6) 2019.With where the burn places were, getting them to heal was a problem because she could not keep it open; she had to go to work and wear pants.She had used the product since she was 14 years old and never had a problem until this one.She thought this one might be faulty or something.She had not been to the doctor; she was trying to treat the burn places at home.Burn places were trying to heal finally.First few days, they were not wanting to scab.She was burned through first layer to second layer of skin; her whole first layer of skin was burned off on (b)(6) 2019.She stated that the product could be left on for 8 hours, but when she experienced the burn, she only left it on for 3-4 hours.Burn places were pretty painful if anything rubs against them.First few days, it was hard for patient to have underwear touching, they were hurting so bad.She stated that her husband can take a picture of the burn places if requested by the safety department.It was a freak thing that happened.She thought it was a little skin burn; the next day on 30mar2019, it was all the way through her skin.She was going to have a scar from the burn as long as it heals.The burn places were in a bad place, so when they tried to ooze, the scab came off and started to bleed.She tried to cover them to keep them from bleeding on 30mar2019.The event burn was related to suspect product, burn places were exactly oval shape of insert inside pad; matched perfectly.The patient classified skin tone as medium, did not have sensitive skin, did not have any abnormal skin conditions.The color of the box was red box.The patient was wearing dress slacks and she adhesive to clothing underwear like the directions.She put the product on at work, but did not engage in exercise while using the product, and then went to a ball game right after.The patient read the usage instructions on thermacare before used the product and checked skin under the product while wearing thermacare probably every 45 minutes or so.And she did not consult a healthcare professional for the problems.She didn't figure it was that bad.She thought she would go by the end of the week if the burn places hadn't started to heal.She had had other burns before, treated them with cream, and kept them covered and clean.Therapeutic measures were taken as a result of all events.The sample of the product was available to be returned.The action taken in response to the events was permanently discontinued on 29mar2019.The outcome of the events was recovering.According to the product quality complaint group: initial complaint assessment: batch af0351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 29apr2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defects recorded for the batch.There were two attribute defects recorded for the batch.Twelve glue nozzles were replaced on glue head 02 during production.One dead cell (individual cell pack not dosed with brine solution) was found during production; pump b31 was realigned.Manufacturing personnel performed the corrective action procedure for each event following the sop-54615 "production quality control - cap procedure" version 4 effective 14dec2015 and form-45377 thermacare corrective action procedure (cap) - individual temperature high/low, version 5 effective 10aug2016.This sop provides instructions to execute equipment trouble shooting when a non-conforming individual cell temperature (cold cell) is observed during the manufacturing process.Pump b31 was found to be out of alignment.The pump was realigned and batch af0351 was completed with no additional oos.The overall thermal data for the batch met the required wrap batch average temperatures (37.6°c to 41.6°c) per menstrual spec-22087, effective: 18jul2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Investigation summary: the root cause category is non assignable (complaint not confirmed as a product quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event of a burn.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.No further investigation or actions are needed.Follow-up (29may2019): new information received from product quality complaint group includes investigation results.Follow-up (30may2019): new information received from a contactable other hcp included: additional reporter.Company clinical evaluation comment based on the information provided, the events of "burn" 'scab" "skin peeling" and "skin bleeding" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn" 'scab" "skin peeling" and "skin bleeding" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Initial complaint assessment: batch af0351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 29apr2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defects recorded for the batch.There were two attribute defects recorded for the batch.Twelve glue nozzles were replaced on glue head 02 during production.One dead cell (individual cell pack not dosed with brine solution) was found during production; pump b31 was realigned.Manufacturing personnel performed the corrective action procedure for each event following the sop-54615 ¿production quality control - cap procedure¿ version 4 effective (b)(6) 2015 and form-45377 thermacare corrective action procedure (cap) - individual temperature high/low, version 5 effective 10aug2016.This sop provides instructions to execute equipment trouble shooting when a non-conforming individual cell temperature (cold cell) is observed during the manufacturing process.Pump b31 was found to be out of alignment.The pump was realigned and batch af0351 was completed with no additional oos.The overall thermal data for the batch met the required wrap batch average temperatures (37.6°c to 41.6°c) per menstr.

Event Description

Event verbatim [preferred term] four to five circular burn places on her stomach/caller was burned through first layer to second layer of skin [thermal burn] , they are starting to scab but are painful [scab] , her whole first layer of skin was burned off [skin exfoliation] , the scab comes off and starts to bleed [skin haemorrhage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 38-year-old (no pregnant, no post-menopausal) female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number af0351, expiration date sep2021, udi number 305733020029, on (b)(6) 2019 at 1 patch placed in underwear for 3-4 hours for menstrual cramps.Medical history included crohn's disease and she did not have to go to the physician right now because she was in remission.There were no concomitant medications.The patient previously took thermacare heatwrap (thermacare menstrual) since she was about 14 years old and did not experience any adverse event.The patient bought thermacare patches that she put in her underwear for menstrual cramps.She got 4-5 burn places on her stomach on 29mar2019.She had used the product for years and never had an issue.The burns were circular, like the things inside the pads.She was having a hard time getting the burns to heal.She put on salve and was trying to keep it open to get the burn places to scab over and heal.They were starting to scab but were painful on (b)(6) 2019.With where the burn places were, getting them to heal was a problem because she could not keep it open; she had to go to work and wear pants.She had used the product since she was 14 years old and never had a problem until this one.She thought this one might be faulty or something.She had not been to the doctor; she was trying to treat the burn places at home.Burn places were trying to heal finally.First few days, they were not wanting to scab.She was burned through first layer to second layer of skin; her whole first layer of skin was burned off on (b)(6) 2019.She stated that the product could be left on for 8 hours, but when she experienced the burn, she only left it on for 3-4 hours.Burn places were pretty painful if anything rubs against them.First few days, it was hard for patient to have underwear touching, they were hurting so bad.She stated that her husband can take a picture of the burn places if requested by the safety department.It was a freak thing that happened.She thought it was a little skin burn; the next day on 30mar2019, it was all the way through her skin.She was going to have a scar from the burn as long as it heals.The burn places were in a bad place, so when they tried to ooze, the scab came off and started to bleed.She tried to cover them to keep them from bleeding on 30mar2019.The event burn was related to suspect product, burn places were exactly oval shape of insert inside pad; matched perfectly.The patient classified skin tone as medium, did not have sensitive skin, did not have any abnormal skin conditions.The color of the box was red box.The patient was wearing dress slacks and she adhesive to clothing underwear like the directions.She put the product on at work, but did not engage in exercise while using the product, and then went to a ball game right after.The patient read the usage instructions on thermacare before used the product and checked skin under the product while wearing thermacare probably every 45 minutes or so.And she did not consult a healthcare professional for the problems.She didn't figure it was that bad.She thought she would go by the end of the week if the burn places hadn't started to heal.She had had other burns before, treated them with cream, and kept them covered and clean.Therapeutic measures were taken as a result of all events.The sample of the product was available to be returned.The action taken in response to the events was permanently discontinued on 29mar2019.The outcome of the events was recovering.According to the product quality complaint group: initial complaint assessment: batch af0351 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defects recorded for the batch.There were two attribute defects recorded for the batch.Twelve glue nozzles were replaced on glue head 02 during production.One dead cell (individual cell pack not dosed with brine solution) was found during production; pump b31 was realigned.Manufacturing personnel performed the corrective action procedure for each event following the sop-54615 "production quality control - cap procedure" version 4 effective 14dec2015 and form-45377 thermacare corrective action procedure (cap) - individual temperature high/low, version 5 effective 10aug2016.This sop provides instructions to execute equipment trouble shooting when a non-conforming individual cell temperature (cold cell) is observed during the manufacturing process.Pump b31 was found to be out of alignment.The pump was realigned and batch af0351 was completed with no additional oos.The overall thermal data for the batch met the required wrap batch average temperatures (37.6°c to 41.6°c) per menstrual spec-22087, effective: 18jul2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Investigation summary: the root cause category is non assignable (complaint not confirmed as a product quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event of a burn.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.No further investigation or actions are needed.Follow-up (29may2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment based on the information provided, the events of "burn" 'scab" "skin peeling" and "skin bleeding" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn" 'scab" "skin peeling" and "skin bleeding" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Four to five circular burn places on her stomach/caller was burned through first layer to second layer of skin [thermal burn] , they are starting to scab but are painful [scab] , her whole first layer of skin was burned off [skin exfoliation] , the scab comes off and starts to bleed [skin haemorrhage].Case narrative: this is a spontaneous report from a contactable consumer.A 38-year-old (not pregnant, not post-menopausal) female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number af0351, expiration date sep2021, udi number (b)(4), on (b)(6) 2019 at 1 patch placed in underwear for 3-4 hours for menstrual cramps.Medical history included crohn's disease and she did not have to go to the physician right now because she was in remission.There were no concomitant medications.The patient previously used thermacare heatwrap (thermacare menstrual) since she was about 14 years old and did not experience any adverse event.The patient bought thermacare patches that she put in her underwear for menstrual cramps.She got 4-5 burn places on her stomach on (b)(6) 2019.She had used the product for years and never had an issue.The burns were circular, like the things inside the pads.She was having a hard time getting the burns to heal.She put on salve and was trying to keep it open to get the burn places to scab over and heal.They were starting to scab but were painful on (b)(6) 2019.With where the burn places were, getting them to heal was a problem because she could not keep it open; she had to go to work and wear pants.She had used the product since she was 14 years old and never had a problem until this one.She thought this one might be faulty or something.She had not been to the doctor; she was trying to treat the burn places at home.Burn places were trying to heal finally.First few days, they were not wanting to scab.She was burned through first layer to second layer of skin; her whole first layer of skin was burned off on (b)(6) 2019.She stated that the product could be left on for 8 hours, but when she experienced the burn, she only left it on for 3-4 hours.Burn places were pretty painful if anything rubs against them.First few days, it was hard for patient to have underwear touching, they were hurting so bad.She stated that her husband can take a picture of the burn places if requested by the safety department.It was a freak thing that happened.She thought it was a little skin burn; the next day on (b)(6) 2019, it was all the way through her skin.She was going to have a scar from the burn as long as it heals.The burn places were in a bad place, so when they tried to ooze, the scab came off and started to bleed.She tried to cover them to keep them from bleeding on (b)(6) 2019.The event burn was related to suspect product, burn places were exactly oval shape of insert inside pad; matched perfectly.The patient classified skin tone as medium, did not have sensitive skin, did not have any abnormal skin conditions.The color of the box was red box.The patient was wearing dress slacks and she adhesive to clothing underwear like the directions.She put the product on at work, but did not engage in exercise while using the product, and then went to a ball game right after.The patient read the usage instructions on thermacare before used the product and checked skin under the product while wearing thermacare probably every 45 minutes or so.And she did not consult a healthcare professional for the problems.She didn't figure it was that bad.She thought she would go by the end of the week if the burn places hadn't started to heal.She had had other burns before, treated them with cream, and kept them covered and clean.Therapeutic measures were taken as a result of all events.The sample of the product was available to be returned.The action taken in response to the events was permanently discontinued on (b)(6) 2019.The outcome of the events was recovering.According to the product quality complaint group: the root cause category is non assignable (complaint not confirmed as a product quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event of a burn.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.No further investigation or actions are needed.Follow-up (05sep2019): follow-up attempts are completed.No further information is expected.Follow-up attempts are completed.No further information is expected.Follow-up (06sep2019): new information received from a product quality complaint group includes: updated investigation summary.Company clinical evaluation comment based on the information provided, the events of "burn", "scab", "skin peeling" and "skin bleeding" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn", "scab", "skin peeling" and "skin bleeding" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a product quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event of a burn.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.No further investigation or actions are needed.

Manufacturer Narrative

Event Description

Four to five circular burn places on her stomach/caller was burned through first layer to second layer of skin [thermal burn], they are starting to scab but are painful [scab], her whole first layer of skin was burned off [skin exfoliation], the scab comes off and starts to bleed [skin haemorrhage].Case narrative: this is a spontaneous report from a contactable consumer.A 38-year-old (not pregnant, not post-menopausal) female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number af0351, expiration date sep2021, udi number (b)(4), on (b)(6) 2019 at 1 patch placed in underwear for 3-4 hours for menstrual cramps and period.Medical history included crohn's disease and she did not have to go to the physician right now because she was in remission.There were no concomitant medications.The patient previously used thermacare heatwrap (thermacare menstrual) for unknown indication since she was about 14 years old and did not experience any adverse event.The patient bought thermacare patches that she put in her underwear for menstrual cramps.She got 4-5 burn places on her stomach on (b)(6) 2019.She had used the product for years and never had an issue.The burns were circular, like the things inside the pads.She was having a hard time getting the burns to heal.She put on salve and was trying to keep it open to get the burn places to scab over and heal.They were starting to scab but were painful on (b)(6) 2019.With where the burn places were, getting them to heal was a problem because she could not keep it open; she had to go to work and wear pants.She had used the product since she was 14 years old and never had a problem until this one.She thought this one might be faulty or something.She had not been to the doctor; she was trying to treat the burn places at home.Burn places were trying to heal finally.First few days, they were not wanting to scab.She was burned through first layer to second layer of skin; her whole first layer of skin was burned off on (b)(6) 2019.She stated that the product could be left on for 8 hours, but when she experienced the burn, she only left it on for 3-4 hours.Burn places were pretty painful if anything rubs against them.First few days, it was hard for patient to have underwear touching, they were hurting so bad.She stated that her husband can take a picture of the burn places if requested by the safety department.It was a freak thing that happened.She thought it was a little skin burn; the next day on (b)(6) 2019, it was all the way through her skin.She was going to have a scar from the burn as long as it heals.The burn places were in a bad place, so when they tried to ooze, the scab came off and started to bleed.She tried to cover them to keep them from bleeding on (b)(6) 2019.The event burn was related to suspect product, burn places were exactly oval shape of insert inside pad; matched perfectly.The patient classified skin tone as medium, did not have sensitive skin, did not have any abnormal skin conditions.The color of the box was red box.The patient was wearing dress slacks and she adhesive to clothing underwear like the directions.She put the product on at work, but did not engage in exercise while using the product, and then went to a ball game right after.The patient read the usage instructions on thermacare before used the product and checked skin under the product while wearing thermacare probably every 45 minutes or so.And she did not consult a healthcare professional for the problems.She didn't figure it was that bad.She thought she would go by the end of the week if the burn places hadn't started to heal.She had had other burns before, treated them with cream, and kept them covered and clean.Therapeutic measures were taken as a result of all events.No admission to hospital involved for all events.The sample of the product was available to be returned.The action taken in response to the events was permanently discontinued on (b)(6) 2019.The outcome of the event the scab comes off and starts to bleed was resolved in 2019 and the outcome of the other events was resolving.It took about 2 months to heel.According to the product quality complaint group: the root cause category is non assignable (complaint not confirmed as a product quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event of a burn.The cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.No further investigation or actions are needed.Severity of harm was s3 for complaint sub-class: adverse event/serious/unknown.Follow-up (29may2019): new information received from product quality complaint group includes investigation results.Follow-up (30may2019): new information received from a contactable other hcp included: additional reporter.Follow-up (05sep2019): follow-up attempts are completed.No further information is expected.Follow-up attempts are completed.No further information is expected.Follow-up (06sep2019): new information received from a product quality complaint group includes: updated investigation summary.Follow-up (04oct2019): this is a follow-up report from a contactable consumer includes device data (updated udi number, indication), outcome of event, stop date of event, deny of hospitalization and device medwatch information (evaluation codes) updated and severity rating.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of "burn", "scab", "skin peeling" and "skin bleeding" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn", "scab", "skin peeling" and "skin bleeding" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.

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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

8528772

MDR Text Key

142480048

Report Number

1066015-2019-00114

Device Sequence Number

Product Code

IMD

UDI-Device Identifier

00305733020029

UDI-Public

305733020029

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,health professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

04/18/2019

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Lay User/Patient

Device Expiration Date

09/01/2021

Device Lot Number

AF0351

Was Device Available for Evaluation?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

38 YR

Patient Weight

127

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

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