MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number CW8011

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

Patient Problems Erythema (1840); Skin Irritation (2076); Burn, Thermal (2530)

Event Type Injury

Event Description

Event verbatim [preferred term] patient complaints of redness and burn like symptoms on skin after usage, she uses thermacare regularly the first patch of the pack worked fine, the second irritated the skin [thermal burn], narrative: this is a spontaneous report from a contactable consumer.A consumer of unspecified age and gender used thermacare heatwrap (thermacare lower back & hip), device lot number cw8011, expiration date 31oct2022, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication.The consumer's medical history and concomitant medications were not reported.The consumer complained of redness and burn like symptoms on skin after usage, she used thermacare regularly the first patch of the pack worked fine, the second irritated the skin on an unspecified date.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Summary of investigations: batch: cw8011 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Conclusion: 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 "redness and burn" and "skin irritations".The cause of the consumer stating the wrap caused "redness and burn" and "skin irritations" 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 any health risk.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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh adverse event-serious-unknown 30-sep-2017 to 30-sep-2020.Site sample status was not received.

Event Description

Patient complaints of redness and burn like symptoms on skin after usage, she uses thermacare regularly the first patch of the pack worked fine, the second irritated the skin [thermal burn], , narrative: this is a spontaneous report from a contactable consumer.A female patient of unspecified age started to use thermacare heatwrap (thermacare lower back & hip), device lot number: cw8011, expiration date: 31oct2022, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient complained of redness and burn like symptoms on skin after usage, she used thermacare regularly the first patch of the pack worked fine, the second irritated the skin on an unspecified date.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: summary of investigations: batch: cw8011 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Conclusion: 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 "redness and burn" and "skin irritations".The cause of the consumer stating the wrap caused "redness and burn" and "skin irritations" 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 any health risk.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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh adverse event-serious-unknown 30-sep-2017 to 30-sep-2020.Site sample status was not received.Follow-up (15oct2020): new information received from the product quality complaint group includes investigational results and updated patient gender.

Manufacturer Narrative

Summary of investigations: batch cw8011 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Conclusion: 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 "redness and burn" and "skin irritations".The cause of the consumer stating the wrap caused "redness and burn" and "skin irritations" 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 any health risk.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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Site sample status was not received.Batch cw8011 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.Trend/complaint history: no lot-specific trend identified; lot trend assmt.And rationale: 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify a potential trend by calculating the complaints per million produced (cpmp) of the subclass.The calculated cpmp result of 15 was below the upper control limit (ucl) of 33.9 a trend was not identified.On the basis of this evaluation, a trend does not exist for this batch.Conclusion 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 redness and burn and skin irritations.The cause of the consumer stating the wrap caused redness and burn and skin irritations 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 any health risk.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] patient complaints of redness and burn like symptoms on skin after usage, she uses thermacare regulary the first patch of the pack worked fine, the second irritated the skin [thermal burn], narrative: this is a spontaneous report from a contactable consumer.A female patient of unspecified age started to use thermacare heatwrap (thermacare lower back & hip), device lot number cw8011, expiration date 31oct2022, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient complained of redness and burn like symptoms on skin after usage, she used thermacare regularly the first patch of the pack worked fine, the second irritated the skin on an unspecified date.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group on (b)(6) 2020: summary of investigations: batch cw8011 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Conclusion: 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 "redness and burn" and "skin irritations".The cause of the consumer stating the wrap caused "redness and burn" and "skin irritations" 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 any health risk.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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Site sample status was not received.According to the product quality complaint group for sub class adverse event safety request for investigation on (b)(6) 2020, site sample status: not received.Summary of investigations: batch: cw8011 brand code/sku#: f00573301064c product count: 6 count; date of manufacture: 19nov2019 to 25nov2019 expiry date: 31oct2022 quantity released: 71,154 cartons.Batch cw8011 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.Trend/complaint history: no lot-specific trend identified; lot trend assmt.And rationale: 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify a potential trend by calculating the complaints per million produced (cpmp) of the subclass.The calculated cpmp result of 15 was below the upper control limit (ucl) of 33.9 a trend was not identified.On the basis of this evaluation, a trend does not exist for this batch.Conclusion 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 redness and burn and skin irritations.The cause of the consumer stating the wrap caused redness and burn and skin irritations 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 any health risk.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 (15oct2020): new information received from the product quality complaint group includes investigational results and updated patient gender.Follow-up (26oct2020): follow-up attempts completed.Case closed.Follow-up (10nov2020): this is a follow-up report from pfizer product quality group providing investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

Event Description

Event verbatim [preferred term] patient complaints of redness and burn like symptoms on skin after usage, she uses thermacare regulary the first patch of the pack worked fine, the second irritated the skin [thermal burn], , narrative: this is a spontaneous report from a contactable consumer.A female patient of unspecified age started to use thermacare heatwrap (thermacare lower back & hip), device lot number cw8011, expiration date 31oct2022, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient complained of redness and burn like symptoms on skin after usage, she used thermacare regularly the first patch of the pack worked fine, the second irritated the skin on an unspecified date.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group on 15oct2020: summary of investigations: batch cw8011 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Conclusion: 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 "redness and burn" and "skin irritations".The cause of the consumer stating the wrap caused "redness and burn" and "skin irritations" 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 any health risk.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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Site sample status was not received.According to the product quality complaint group for sub class adverse event safety request for investigation on 10nov2020, site sample status: not received.Summary of investigations: batch: cw8011 brand code/sku#: f00573301064c product count: (b)(4) count; date of manufacture: 19nov2019 to 25nov2019 expiry date: 31oct2022 quantity released: (b)(4)cartons.Batch cw8011 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.Trend/complaint history: no lot-specific trend identified; lot trend assmt.And rationale: 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify a potential trend by calculating the complaints per million produced (cpmp) of the subclass.The calculated cpmp result of 15 was below the upper control limit (ucl) of 33.9 a trend was not identified.On the basis of this evaluation, a trend does not exist for this batch.Conclusion 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 redness and burn and skin irritations.The cause of the consumer stating the wrap caused redness and burn and skin irritations 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 any health risk.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 device complaint handling unit (dchu): severity of harm was s3.Follow-up (15oct2020): new information received from the product quality complaint group includes investigational results and updated patient gender.Follow-up (26oct2020): follow-up attempts completed.Case closed.Follow-up (10nov2020): this is a follow-up report from pfizer product quality group providing investigation results.Follow-up (19jan2021): new information received from device complaint handling unit (dchu) included: severity of harm.Follow-up attempts are completed.No further information is expected.

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Brand Name

THERMACARE LOWER BACK & HIP

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

10678615

MDR Text Key

211344817

Report Number

1066015-2020-00173

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

consumer,foreign

Type of Report

Initial,Followup,Followup,Followup

Report Date

09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

10/14/2020

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Lay User/Patient

Device Expiration Date

10/31/2022

Device Lot Number

CW8011

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 LOWER BACK & HIP; DISPOSABLE PACK, HOT

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