MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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Lot Number X25940

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Pain (1994); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 01/04/2019

Event Type Injury

Event Description

Event verbatim [preferred term] it burnt my arm/still have a blister, probably half a inch and 2 small blister [burns second degree] , sleeping with it like i normally do while i was wearing the product [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 63-year-old female patient (weight: 98.88 kg, height: 164 cm) started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number x25940, expiration date aug2021) from 04jan2019 to 04jan2019 at 1 pad, "use them quite regularly, for long time for pain under my arms, it goes from under my arm to around my back/for aching, pain, and for fibromyalgia".Thermacare was recommended by her physician because she had fibromyalgia.Medical history included ongoing diabetes mellitus from 1984, fibromyalgia, psoriatic arthritis, asthma, congestive heart failure, hypertension, peripheral neuropathy, palmoplantar psoriasis, "have psoriasis on feet", coronary heart disease, shoulder pain, muscle pain, shingles on back, blood pressure abnormal, heart disorder.When probed if patient had difficulty feeling heat or pain on skin, replied "yes, in my feet." patient's skin tone was light.Concomitant medications included ongoing ibuprofen "assured" (lot#: s1809003; expiration date: jan2020) for shoulder and fibromyalgia, ongoing metformin tablet 1000 (no units provided) twice a day from "somewhere around 1995" for diabetes, ongoing insulin aspart (novolog, flex pen) 10 units twice (10 in morning and 10 in afternoon) and 15 units at night from 1997 for diabetes, and ongoing insulin detemir (levemir, "flex touch") 60 units in morning and 60 units at night since about mar2018 for diabetes, ongoing metaxalone (skelaxin) from (b)(6)2019 for fibromyalgia pain and muscle pain, valaciclovir (valacyclovir) from (b)(6)2019 to unknown date, and from(b)(6)2019 to (b)(6)2019 for shingles on back, ongoing amlodipine from 2004 for blood pressure and heart.The patient previously took insulin glargine (lantus) for diabetes.The patient also previously used other heat products for pain relief, which was called "bed buddy, which just heat them in the microwave oven but i did not use them this time." patient previously used thermacare, and did not experienced a problem/symptom with any one of them, never had any problem or anything.The patient use thermacare heatwrap, and experienced "it burnt my arm" on (b)(6)2019.The patient "was sleeping, i did sleeping with it like i normally do while i was wearing the product." when it started hurting, that's when she took it off." patient had to go to the urgent care center and get treatment on friday(b)(6) 2019.The patient reported that she still had "a blister, probably half an inch and 2 small blister" at the time of reporting (b)(6) 2019.This was the first time this is ever happened.Patient reported "i am a diabetic and it was hurting pretty much.I am out of breath, i went to the urgent care center.When i took it off i was hurting so that's where i wanted to go to the doctor for them to look at it and prescribe me some medication" on an unspecified date.The patient consulted "doctor and physician" for the problem.The patient reported some of the pain on her back was the shingles- on back only.The pain on her left arm was made worse by the shingles.She put the thermacare under that arm and got a burn within 6 hours, then went to local hospital (clinic name)- treated at clinic by (physician name) dr.Middle at (name) for follow up by phone & visit.On (b)(6) 2019 she purchased a package of thermacare advanced neck, wrist and shoulder heat wraps.She applied one under her arm about 2 inches down from the arm pit it was on about 5 hours and she started experiencing pain and itching different from the pain she had applied it for.She had used the heat wraps for many years for some relief for neck, shoulder and under arm and never experienced this.She had to remove it in the early hours of the morning due to this terrible pain of burning and it had an smell as well.She later took a shower.She looked under her arm and saw the burn.Her back continued to hurt as well (nerve pain due to the shingles).So she went to our (hospital name).Where they did find she had shingles which is why she was hurting in back.They attended the burn under her arm approx.2 inches under her arm pit prescribed silver sulfadiazine 1% 85 mg to be applied 3-4 times daily after cleaned with antibacterial soap and cover the wound.She was also prescribed medication for shingles on my back.She continue to do this until around (b)(6) 2019.She had enclosed pictures of her injury under arm pit.The patient was hospitalized for sleeping with it like i normally do while i was wearing the product, went completely just under my arm/used the heatwrap for fibromyalgia and out of breath.Therapeutic measures were taken as a result of the events.Patient did not have any lab work.Patient read the usage instructions on thermacare before using the product.The patient was not engaged in exercise while using the product.The heat wrap was attached to the adhesive to the body.There was no remaining product, "the other two didn't bother me.It was just this, the last one that i used in the box." ndc number: 0573301502, and upc number: 305733015025 for thermacare heatwrap "red box" provided.The action taken with thermacare heatwrap was permanently discontinued.The outcome of all events was resolved.According to product quality complaint (pqc) group: batch x25940 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 with 3 pouched wraps inside.There were no obvious defects observed.Form-# retain sample inspection form documented the retain evaluation performed on 07mar2019.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.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(37.6c - 41.6°c) per neck shoulder wrist unprinted spec-34819; effective date: 17may2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.Return sample was received by site, and complaint was not confirmed.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 "burnt my arm".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 (18mar2019 and 02apr2019): new information received from product quality complaint group includes investigation results.Follow up (04jun2019): new information received from a contactable consumer included: suspect product data (start date, stop date, dose, action taken), medical history, concomitant medications, event details, event onset date and stop date, treatment received and hospitalization information.Company clinical evaluation comment: based on the information provided, the events of burns second degree and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure; and assessed as associated with the use of the device.The patient was hospitalized for events intentional device use issue and dyspnoea; and assessed as not 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 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 burns second degree and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure; and assessed as associated with the use of the device.The patient was hospitalized for events intentional device use issue and dyspnoea; and assessed as not 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 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

Batch x25940 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 with 3 pouched wraps inside.There were no obvious defects observed.Form-# retain sample inspection form documented the retain evaluation performed on 07mar2019.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.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(37.6c - 41.6°c) per neck shoulder wrist unprinted spec-34819; effective date: 17may2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.Investigation summary: 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 "burnt my arm".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.

Manufacturer Narrative

Event Description

Event verbatim [preferred term] it burnt my arm/still have a blister, probably half a inch and 2 small blister [burns second degree] , sleeping with it like i normally do while i was wearing the product [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 63-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number x25940, expiration date aug2021) from 04jan2019 to 04jan2019 at 1 pad, "use them quite regularly, for long time for pain under my arms, it goes from under my arm to around my back/for aching, pain, and for fibromyalgia".Thermacare was recommended by her physician because she had fibromyalgia.Medical history included ongoing diabetes mellitus from 1984, fibromyalgia, psoriatic arthritis, asthma, congestive heart failure, hypertension, peripheral neuropathy, palmoplantar psoriasis, "have psoriasis on feet", coronary heart disease, shoulder pain, muscle pain, shingles on back, blood pressure abnormal, heart disorder.When probed if patient had difficulty feeling heat or pain on skin, replied "yes, in my feet." patient's skin tone was light.Concomitant medications included ongoing ibuprofen "assured" (lot#: s1809003; expiration date: jan2020) for shoulder and fibromyalgia, ongoing metformin tablet from "somewhere around 1995" for diabetes, ongoing insulin aspart (novolog, flex pen) 10 units twice (10 in morning and 10 in afternoon) and 15 units at night from 1997 for diabetes, and ongoing insulin detemir (levemir, "flex touch") 60 units in morning and 60 units at night since about mar2018 for diabetes, ongoing metaxalone (skelaxin) from 03jan2019 for fibromyalgia pain and muscle pain, valaciclovir (valacyclovir) from 05jan2019 to unknown date, and from 15jan2019 to 22jan2019 for shingles on back, ongoing amlodipine from 2004 for blood pressure and heart.The patient previously took insulin glargine (lantus) for diabetes.The patient also previously used other heat products for pain relief, which was called "bed buddy, which just heat them in the microwave oven but i did not use them this time." patient previously used thermacare heatwrap, and did not experience a problem/symptom with any one of them, never had any problem or anything.The patient use thermacare heatwrap, and experienced "it burnt my arm" on 04jan2019.The patient "was sleeping, i did sleeping with it like i normally do while i was wearing the product." when it started hurting, that's when she took it off." patient had to go to the urgent care center and get treatment on friday (04jan2019).The patient reported that she still had "a blister, probably half an inch and 2 small blister" at the time of reporting 07jan2019.This was the first time this is ever happened.Patient reported "i am a diabetic and it was hurting pretty much.I am out of breath, i went to the urgent care center.When i took it off i was hurting so that's where i wanted to go to the doctor for them to look at it and prescribe me some medication" on an unspecified date.The patient consulted "doctor and physician" for the problem.The patient reported some of the pain on her back was the shingles- on back only.The pain on her left arm was made worse by the shingles.She put the thermacare under that arm and got a burn within 6 hours, then went to local hospital (clinic name)- treated at clinic by (physician name) dr.Middle at (name) for follow up by phone & visit.On 03jan2019.She purchased a package of thermacare advanced neck, wrist and shoulder heat wraps.She applied one under her arm about 2 inches down from the arm pit it was on about 5 hours and she started experiencing pain and itching different from the pain she had applied it for.She had used the heat wraps for many years for some relief for neck, shoulder and under arm and never experienced this.She had to remove it in the early hours of the morning due to this terrible pain of burning and it had an smell as well.She later took a shower.She looked under her arm and saw the burn.Her back continued to hurt as well (nerve pain due to the shingles).So she went to our (hospital name).Where they did find she had shingles which is why she was hurting in back.They attended the burn under her arm approx.2 inches under her arm pit prescribed silver sulfadiazine 1% 85 mg to be applied 3-4 times daily after cleaned with antibacterial soap and cover the wound.She was also prescribed medication for shingles on my back.She continue to do this until around 30jan2019.She had enclosed pictures of her injury under arm pit.The patient was hospitalized for sleeping with it like i normally do while i was wearing the product, went completely just under my arm/used the heatwrap for fibromyalgia and out of breath.Therapeutic measures were taken as a result of the events.Patient did not have any lab work.Patient read the usage instructions on thermacare before using the product.The patient was not engaged in exercise while using the product.The heat wrap was attached to the adhesive to the body.There was no remaining product, "the other two didn't bother me.It was just this, the last one that i used in the box." ndc number: 0573301502, and udi number: 305733015025 for thermacare heatwrap "red box" provided.The action taken with thermacare heatwrap was permanently discontinued.The outcome of all events was resolved.According to product quality complaint (pqc) group: batch x25940 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 with 3 pouched wraps inside.There were no obvious defects observed.Form-# retain sample inspection form documented the retain evaluation performed on 07mar2019.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.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(37.6c - 41.6°c) per neck shoulder wrist unprinted spec-34819; effective date: 17may2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.Return sample was received by site, and complaint was not confirmed.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 "burnt my arm".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 product quality complaint (pqc) group: the visual inspection of a retain sample included one carton and the two pouched wraps inside and showed no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 10jun2019 for an unrelated sample.An evaluation of the complaint history confirms that this is the second complaint for the subclass adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing process root cause of adverse event safety request for investigation.On the basis of this evaluation, a trend does not exist for this batch.There is not a trend identified for the subclass of adverse events safety request for investigation.Refer to the batch process review record and the 24 month trend chart attached.Severity of harm: s3.No device malfunction was identified.There is no further action required.Follow-up (18mar2019 and 02apr2019): new information received from product quality complaint group includes investigation results.Follow up (04jun2019): new information received from a contactable consumer included: suspect product data (start date, stop date, dose, action taken), medical history, concomitant medications, event details, event onset date and stop date, treatment received and hospitalization information.Follow-up (19jun2019): new information received from the product quality complaint group includes investigational results company clinical evaluation comment: based on the information provided, the events of burns second degree and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure; and assessed as associated with the use of the device.The patient was hospitalized for events intentional device use issue and dyspnoea; and assessed as not 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 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 burns second degree and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure; and assessed as associated with the use of the device.The patient was hospitalized for events intentional device use issue and dyspnoea; and assessed as not 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 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

It burnt my arm/still have a blister, probably half a inch and 2 small blister [burns second degree], sleeping with it like i normally do while i was wearing the product [intentional device misuse], went completely just under my arm/used the heatwrap for fibromyalgia [intentional device use issue], i am out of breath [dyspnoea].Case narrative: this is a spontaneous report from a contactable consumer.A 63-year-old female patient (weight: 98.88 kg, height: 164 cm) started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: x25940, expiration date: aug2021) via an unspecified route of administration, "use them quite regularly, for long time for pain under my arms, it goes from under my arm to around my back/for aching, pain, and for fibromyalgia".Thermacare was recommended by her physician because she had fibromyalgia.Medical history included ongoing diabetes mellitus from 1984, fibromyalgia, psoriatic arthritis, asthma, congestive heart failure, hypertension, peripheral neuropathy, palmoplantar psoriasis, "have psoriasis on feet", and coronary heart disease.When probed if patient had difficulty feeling heat or pain on skin, replied "yes, in my feet." patient's skin tone was light.Concomitant medications included ibuprofen "assured" (lot#: s1809003; expiration date: jan2020), ongoing metformin tablet 1000 (no units provided) twice a day from "somewhere around 1995" for diabetes, ongoing insulin aspart (novolog, flex pen) 10 units twice (10 in morning and 10 in afternoon) and 15 units at night from 1997 for diabetes, and ongoing insulin detemir (levemir, "flex touch") 60 units in morning and 60 units at night since about on (b)(6) 2018 for diabetes.The patient previously took insulin glargine (lantus) for diabetes.The patient also previously used other heat products for pain relief, which was called "bed buddy, which just heat them in the microwave oven but i did not use them this time." patient previously used thermacare, and did not experienced a problem/symptom with any one of them, never had any problem or anything.The patient use thermacare heatwrap, "it went completely just under my arm, i would say probably about less than 4 hours", and experienced "it burnt my arm" on (b)(6) 2019.The patient "was sleeping, i did sleeping with it like i normally do while i was wearing the product." when it started hurting, that's when she took it off." patient had to go to the urgent care center and get treatment on friday (on (b)(6) 2019).They gave the patient some silver sulfadiazine cream 1%.The patient reported that she still had "a blister, probably half an inch and 2 small blister" at the time of reporting on (b)(6) 2019.This was the first time this is ever happened.Patient reported "i am a diabetic and it was hurting pretty much.I am out of breath, i went to the urgent care center.When i took it off i was hurting so that's where i wanted to go to the doctor for them to look at it and prescribe me some medication" on an unspecified date.The patient consulted "doctor and physician" for the problem.Therapeutic measures were taken as a result of the events.Patient did not have any lab work.Patient read the usage instructions on thermacare before using the product.The patient was not engaged in exercise while using the product.The heat wrap was attached to the adhesive to the body.There was no remaining product, "the other two didn't bother me.It was just this, the last one that i used in the box." ndc number: 0573301502, and upc number: 305733015025 for thermacare heatwrap "red box" provided.The action taken with thermacare heatwrap was unknown.The outcome of the event it burnt my arm/still have a blister, probably half a inch and 2 small blister was not recovered, and for the rest of the events was unknown.According to product quality complaint (pqc) group: batch: x25940 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 with 3 pouched wraps inside.There were no obvious defects observed.Form-# retain sample inspection form documented the retain evaluation performed on 07mar2019.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.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 (37.6c - 41.6°c) per neck shoulder wrist unprinted spec-34819; effective date: 17may2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.Investigation summary: 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 "burnt my arm".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 (18mar2019 and 02apr2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the events of burns second degree 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 intentional device use issue and dyspnoea are non-serious.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 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 burns second degree 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 intentional device use issue and dyspnoea are non-serious.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 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

Batch: x25940 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 with 3 pouched wraps inside.There were no obvious defects observed.Form-# retain sample inspection form documented the retain evaluation performed on 07mar2019.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.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(37.6c - 41.6°c) per neck shoulder wrist unprinted spec-34819; effective date: 17may2018.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.Investigation summary: 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 "burnt my arm".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.

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Brand Name

THERMACARE NECK, SHOULDER & WRIST

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

8260481

MDR Text Key

133543198

Report Number

1066015-2019-00010

Device Sequence Number

Product Code

IMD

UDI-Device Identifier

00305733015025

UDI-Public

305733015025

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

01/07/2019

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

X25940

Was Device Available for Evaluation?

Yes

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

01/18/2019

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided

Supplement Dates FDA Received

04/09/2019
06/17/2019
06/25/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Treatment

AMLODIPINE; AMLODIPINE; AMLODIPINE; AMLODIPINE; IBUPROFEN; IBUPROFEN; IBUPROFEN; IBUPROFEN; IBUPROFEN; LEVEMIR; LEVEMIR; LEVEMIR; LEVEMIR; METFORMIN; METFORMIN; METFORMIN; METFORMIN; NOVOLOG; NOVOLOG; NOVOLOG; NOVOLOG; SKELAXIN [METAXALONE]; SKELAXIN [METAXALONE]; SKELAXIN [METAXALONE]; SKELAXIN [METAXALONE]; VALACYCLOVIR [VALACICLOVIR]; VALACYCLOVIR [VALACICLOVIR]; VALACYCLOVIR [VALACICLOVIR]; VALACYCLOVIR [VALACICLOVIR]; LEVEMIR; METFORMIN; NOVOLOG

Patient Outcome(s)

Hospitalization; Other; Required Intervention;

Patient Age

63 YR

Patient Weight

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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