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 AD3823

Device Problems Nonstandard Device (1420); Use of Device Problem (1670)

Patient Problems Erythema (1840); Irritation (1941); Swelling (2091); Burning Sensation (2146); Discomfort (2330); Partial thickness (Second Degree) Burn (2694)

Event Type Injury

Event Description

Manufacturer Narrative

Batch ad3823 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 05feb2019, a visual examination was performed to identify if a potential trend exist for the lot with the subclasses adverse event safety request for investigation, adverse event/serious/unknown, and adverse event/negligible/minor.No trend was identified.Refer to attachment ad3823 adverse event trending graph.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 attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c) per spec-29842, effective: 24aug2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, 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 a "blister." the cause of the blister is inconclusive since review of records does not provide evidence to.

Event Description

Event verbatim [preferred term] blister/felt like an irritation/it was very red/ the blister was very definitely from burn caused by the thermacare wrap/feel a little uncomfortable/burning sensation [burns second degree] , did not check her skin under the product while wearing thermacare/read the usage instructions on thermacare before she used the product [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 77-years-old female patient (no pregnant) started to receive thermacare heatwrap (thermacare lower back & hip) device lot number ad3823, expiry date aug2021, udi number (b)(4), ndc number 0573301003, from an unspecified date to an unspecified date at put it on and then leave it for whatever the hours it had said and then take it off for pain in her lower left back just near the hip area, lower back and hip pain left side.Medical history included thyroid issues which were currently under the care of a physician, arthritis and post-menopausal.There were no concomitant medications.The patient previously took thermacare heatwraps for many years for unknown indication and never had a problem with it.The patient occasionally also used a heating pad from many years for pain relief and did not experience any problem or symptom.The patient stated that she was just reporting that she did have a reaction to one of the thermacare lower back and hip heatwraps that had been recalled.She had a blister from it this was probably she didn't know maybe months ago.She stated that the first sign, she noticed like an irritation, it felt like an irritation and when she looked she could see that it was very red so then she got a mirror and looked closer and could see a blister.She confirmed that there was no primary healthcare professional involved.She thought if she remembered right she put like an antibiotic cream on it for event blister.She stated that there was one left in the box and she didn't use it again.The patient further stated that it started to feel a little uncomfortable so repositioned and lasted for 2 hours.She had burning sensation and lasted for 2 days.The blister was very definitely from burn caused by the thermacare wrap.She treated it with neosporin ointment.No admission to hospital involved for the event blister, felt like an irritation and it was very red.She also did not consult a healthcare professional for the symptoms.She classified her skin tone as medium (neither light nor dark).She had no sensitive skin.She had no abnormal skin conditions.She purchased red box.She used thermacare for 4 hours that day.She was wearing several layers of clothing over the thermacare product.She had blouse and light weight jacket and riding in car for 2 hrs.When she was wearing thermacare, she wasn't sleeping.She never went on to bed.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare and she stated that it was still on there.She read the usage instructions on thermacare before she used the product.The action taken in response to the events for thermacare heatwrap was permanently withdrawn at same day as problem happened.The outcome of the event blister/felt like an irritation/it was very red/ the blister was very definitely from burn caused by the thermacare wrap/feel a little uncomfortable/burning sensation was resolved and the outcome of the other event was unknown.According to product quality complaints, batch ad3823 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 05feb2019, a visual examination was performed to identify if a potential trend exist for the lot with the subclasses adverse event safety request for investigation, adverse event/serious/unknown, and adverse event/negligible/minor.No trend was identified.Refer to attachment ad3823 adverse event trending graph.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 attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c) per spec-29842, effective: 24aug2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, 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 a "blister." the cause of the blister 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.Follow-up ((b)(6) 2019): new information received from a contactable consumer includes patient data, medical history, concomitant drug data, device data (indication) and information, new event information (the blister was very definitely from burn caused by the thermacare wrap, feel a little uncomfortable and burning sensation), treatment details, deny of hospitalization, outcome of event and case upgraded to a serious reportable mdr.Follow-up ((b)(6) 2019): follow-up attempts completed.No further information expected.Follow-up ((b)(6) 2019): new information received from product quality complaints included: investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events of "burn blister" and "intentional device misuse" 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.In the case narrative there is evidence of "intentional device misuse" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn blister" and "intentional device misuse" 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.In the case narrative there is evidence of "intentional device misuse" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

According to product quality complaints, batch ad3823 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 05feb2019, a visual examination was performed to identify if a potential trend exist for the lot with the subclasses adverse event safety request for investigation, adverse event/serious/unknown, and adverse event/negligible/minor.No trend was identified.Refer to attachment ad3823 adverse event trending graph.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 (city) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist for this batch.Based on customizable search for the subclass of adverse event/serious/unknown for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh products, refer to attachment lbh adverse event serious unknown aug2017 to aug2019.Based on this customizable search for the subclass of adverse event/serious/unknown for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh products, refer to attachment lbh adverse event serious unknown aug2017 to aug2019.On the basis of this evaluation, a trend does not exist for this batch.Review of the b.

Event Description

Blister/felt like an irritation/it was very red/ the blister was very definitely from burn caused by the thermacare wrap/feel a little uncomfortable/burning sensation [burns second degree], did not check her skin under the product while wearing thermacare/read the usage instructions on thermacare before she used the product [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A 77-years-old female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip) device lot number ad3823, expiry date aug2021, udi number (b)(4), ndc number 0573301003, from an unspecified date to an unspecified date at put it on and then leave it for whatever the hours it had said and then take it off for pain in her lower left back just near the hip area, lower back and hip pain left side.Medical history included thyroid issues which were currently under the care of a physician, arthritis and post-menopausal.There were no concomitant medications.The patient previously took thermacare heatwraps for many years for unknown indication and never had a problem with it.The patient occasionally also used a heating pad from many years for pain relief and did not experience any problem or symptom.The patient stated that she was just reporting that she did have a reaction to one of the thermacare lower back and hip heatwraps that had been recalled.She had a blister from it this was probably she didn't know maybe months ago.She stated that the first sign, she noticed like an irritation, it felt like an irritation and when she looked she could see that it was very red so then she got a mirror and looked closer and could see a blister.She confirmed that there was no primary healthcare professional involved.She thought if she remembered right she put like an antibiotic cream on it for event blister.She stated that there was one left in the box and she didn't use it again.The patient further stated that it started to feel a little uncomfortable so repositioned and lasted for 2 hours.She had burning sensation and lasted for 2 days.The blister was very definitely from burn caused by the thermacare wrap.She treated it with neosporin ointment.No admission to hospital involved for the event blister, felt like an irritation and it was very red.She also did not consult a healthcare professional for the symptoms.She classified her skin tone as medium (neither light nor dark).She had no sensitive skin.She had no abnormal skin conditions.She purchased red box.She used thermacare for 4 hours that day.She was wearing several layers of clothing over the thermacare product.She had blouse and light weight jacket and riding in car for 2 hrs.When she was wearing thermacare, she wasn't sleeping.She never went on to bed.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare and she stated that it was still on there.She read the usage instructions on thermacare before she used the product.The action taken in response to the events for thermacare heatwrap was permanently withdrawn at same day as problem happened.The outcome of the event blister/felt like an irritation/it was very red/ the blister was very definitely from burn caused by the thermacare wrap/feel a little uncomfortable/burning sensation was resolved and the outcome of the other event was unknown.According to product quality complaints, batch ad3823 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 05feb2019, a visual examination was performed to identify if a potential trend exist for the lot with the subclasses adverse event safety request for investigation, adverse event/serious/unknown, and adverse event/negligible/minor.No trend was identified.Refer to attachment ad3823 adverse event trending graph.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 (city) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist for this batch.Based on customizable search for the subclass of adverse event/serious/unknown for lbh products the data did not show an increase over time (24 months).There is not a trend identified for the subclass of adverse event/serious/unknown for lbh products, refer to attachment lbh adverse event serious unknown aug2017 to aug2019.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 attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c) per spec-29842, effective: 24aug2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, 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 a "blister." the cause of the blister 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.According to the product quality complaint group: severity of harm was s3.Follow-up (21may2019): new information received from a contactable consumer includes patient data, medical history, concomitant drug data, device data (indication) and information, new event information (the blister was very definitely from burn caused by the thermacare wrap, feel a little uncomfortable and burning sensation), treatment details, deny of hospitalization, outcome of event and case upgraded to a serious reportable mdr.Follow-up (18jul2019): follow-up attempts completed.No further information expected.Follow-up (21aug2019): new information received from product quality complaints included: investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (27aug2019): new information received from the product quality complaint group includes severity assessment.Follow-up attempts are completed.No further information is expected.Follow up (26sep2019): new information from product quality complaint includes: additional investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of "burn blister" and "intentional device misuse" 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.In the case narrative there is evidence of "intentional device misuse" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events of "burn blister" and "intentional device misuse" 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.In the case narrative there is evidence of "intentional device misuse" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Blister/felt like an irritation/it was very red/ the blister was very definitely from burn caused by the thermacare wrap/feel a little uncomfortable/burning sensation [burns second degree], did not check her skin under the product while wearing thermacare/read the usage instructions on thermacare before she used the product [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A 77-years-old female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip) device lot number ad3823, expiry date aug2021, udi number (b)(4), ndc number 0573301003, from an unspecified date to an unspecified date at put it on and then leave it for whatever the hours it had said and then take it off for pain in her lower left back just near the hip area, lower back and hip pain left side.Medical history included thyroid issues which were currently under the care of a physician, arthritis and post-menopausal.There were no concomitant medications.The patient previously took thermacare heatwraps for many years for unknown indication and never had a problem with it.The patient occasionally also used a heating pad from many years for pain relief and did not experience any problem or symptom.The patient stated that she was just reporting that she did have a reaction to one of the thermacare lower back and hip heatwraps that had been recalled.She had a blister from it this was probably she didn't know maybe months ago.She stated that the first sign, she noticed like an irritation, it felt like an irritation and when she looked she could see that it was very red so then she got a mirror and looked closer and could see a blister.She confirmed that there was no primary healthcare professional involved.She thought if she remembered right she put like an antibiotic cream on it for event blister.She stated that there was one left in the box and she didn't use it again.The patient further stated that it started to feel a little uncomfortable so repositioned and lasted for 2 hours.She had burning sensation and lasted for 2 days.The blister was very definitely from burn caused by the thermacare wrap.She treated it with neosporin ointment.No admission to hospital involved for the event blister, felt like an irritation and it was very red.She also did not consult a healthcare professional for the symptoms.She classified her skin tone as medium (neither light nor dark).She had no sensitive skin.She had no abnormal skin conditions.She purchased red box.She used thermacare for 4 hours that day.She was wearing several layers of clothing over the thermacare product.She had blouse and light weight jacket and riding in car for 2 hrs.When she was wearing thermacare, she wasn't sleeping.She never went on to bed.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare and she stated that it was still on there.She read the usage instructions on thermacare before she used the product.The action taken in response to the events for thermacare heatwrap was permanently withdrawn at same day as problem happened.The outcome of the event blister/felt like an irritation/it was very red/ the blister was very definitely from burn caused by the thermacare wrap/feel a little uncomfortable/burning sensation was resolved and the outcome of the other event was unknown.According to product quality complaints, batch ad3823 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation received at the (city name) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 05feb2019, a visual examination was performed to identify if a potential trend exist for the lot with the subclasses adverse event safety request for investigation, adverse event/serious/unknown, and adverse event/negligible/minor.No trend was identified.Refer to attachment ad3823 adverse event trending graph.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 attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c) per spec-29842, effective: 24aug2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, 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 a "blister." the cause of the blister 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.According to the product quality complaint group: severity of harm was s3.Follow-up (21may2019): new information received from a contactable consumer includes patient data, medical history, concomitant drug data, device data (indication) and information, new event information (the blister was very definitely from burn caused by the thermacare wrap, feel a little uncomfortable and burning sensation), treatment details, deny of hospitalization, outcome of event and case upgraded to a serious reportable mdr.Follow-up (18jul2019): follow-up attempts completed.No further information expected.Follow-up (21aug2019): new information received from product quality complaints included: investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of "burn blister" and "intentional device misuse" 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.In the case narrative there is evidence of "intentional device misuse" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.Follow-up (27aug2019): new information received from the product quality complaint group includes severity assessment.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of "burn blister" and "intentional device misuse" 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.In the case narrative there is evidence of "intentional device misuse" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events of "burn blister" and "intentional device misuse" 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.In the case narrative there is evidence of "intentional device misuse" which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

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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

8658201

MDR Text Key

146898469

Report Number

1066015-2019-00176

Device Sequence Number

Product Code

IMD

UDI-Device Identifier

00305733010037

UDI-Public

305733010037

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer

Type of Report

Initial,Followup,Followup,Followup

Report Date

05/01/2019

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?

Device Operator

Lay User/Patient

Device Expiration Date

08/01/2021

Device Lot Number

AD3823

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

05/31/2019

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided

Supplement Dates FDA Received

09/03/2019
09/26/2019
10/15/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

77 YR

Patient Weight

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

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