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 M61533; N27782

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Pain (1994); Full thickness (Third Degree) Burn (2696)

Event Date 01/01/2017

Event Type Injury

Event Description

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Nurse alleges she got "a third degree burn" from a wrap.The cause of the alleged wrap having "believes that there was just something wrong with that particular heat wrap" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The return sample (lot number: m61533) does not explain why the wrap was too hot.

Event Description

Event verbatim [preferred term] third degree burns [burns third degree] , blistered and open [blister] , blistered and open [wound] , draining yellow discharge [purulent discharge] , applied heatwrap and went to bed; wore more than 2 layers of clothing over the heatwrap [intentional device misuse] , applied heatwrap and went to bed; wore more than 2 layers of clothing over the heatwrap [device use error] , believes that there was just something wrong with that particular heat wrap/wrap was too hot [device issue] , pain [pain] , still read and is itchy at times [pruritus] , still read and is itchy at times [erythema] ,.Case narrative:this is a spontaneous report from a contactable retired nurse reporting on behalf of herself.This (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip)(device lot number: m61533, expiration date: oct2018 also reported as device lot number n27782, expiration date mar2019) from (b)(6) 2017 sporadically as needed for pain.Medical history included neuropathy from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, cervical dystonia from an unknown date and unknown if ongoing (three neck surgeries after car accidents), osteoarthritis from an unknown date and unknown if ongoing, pre-diabetes from an unknown date and unknown if ongoing, chronic pain from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing, eczema from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, acid reflux from an unknown date and unknown if ongoing, irritable bowel from an unknown date and unknown if ongoing, overactive bladder from an unknown date and unknown if ongoing, migraines from an unknown date and unknown if ongoing, anemic from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing, low potassium from an unknown date and unknown if ongoing, fluid retention from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, muscle pain from an unknown date and unknown if ongoing , low vitamin d from an unknown date and unknown if ongoing, skin sensitization from an unknown date and unknown if ongoing, gastric bypass surgery (20 plus years ago) from an unknown date and unknown if ongoing, neck surgery from an unknown date and unknown if ongoing, car accident from an unknown date and unknown if ongoing, shingles from an unknown date and unknown if ongoing, sensitive skin from an unknown date and unknown if ongoing, post-menopausal from an unknown date and unknown if ongoing and skin fissures from an unknown date and unknown if ongoing.Concomitant medication included pregabalin (lyrica), hydrocodone bitartrate, paracetamol (vicodin), botulinum toxin type a (botox), omeprazole, sodium bicarbonate (zegerid), ranitidine (ranitidine), cetirizine hydrochloride (zyrtec d), potassium chloride (potassium chloride), hydrochlorothiazide (hydrochlorothiazide), cyanocobalamin (vitamin b12), lidocaine (lidoderm) , mometasone furoate (flonase), budesonide, formoterol fumarate (symbicort), salbutamol (albuterol), ipratropium bromide, salbutamol sulfate (duoneb), epinephrine (epipen), montelukast sodium (singulair), omeprazole (protonix), ondansetron (zofran), chlordiazepoxide hydrochloride, clidinium bromide (librax), diazepam (valium), solifenacin succinate (vesicare), ergocalciferol (vitamin d), butalbital, caffeine, paracetamol (fioricet), fluorine and xylitol (biotene).Past product history included alpha lipoic acid for neuropathy peripheral and experienced drug ineffective, condition aggravated and gastric disorder; and thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient has used thermacare products for a long time and has never had an issue.On (b)(6) 2017 she applied a thermacare back heatwrap to her back and went to bed.She woke up a few times over the night, adjusted the heatwrap and checked her skin before going back to sleep.She woke up in pain sometime on (b)(6) 2017, after wearing the heatwrap for 3 to 4 hours, and discovered that her entire right hip where the heatwrap was applied was red with a spot slightly larger than a silver dollar that was blistered with an open sore.She initially thought she had shingles, but has already had shingles twice and received the vaccine.She went to an urgent care office and was told by a physician's assistant (pa) she had a third degree burn.By the time she went to the urgent care facility, it was draining yellow discharge.The patient stated the burn has improved with no more discharge, no open wound and is no longer painful, but it is still red and itchy at times.She thinks it might leave a scar.The patient mentioned she wore several layers of clothing (wore underwear and her pajamas) over the heatwrap during use and wore a snug waistband/belt or similar or otherwise applied pressure over the area.She no longer has the heatwrap she used to provide as a sample for further investigation.The patient assessed her skin tone as fair.She currently sees a neurologist for neuropathy and a dermatologist for eczema, skin fissures and sensitive skin.The patient mentioned she is on other medications, but nothing that was applied topically to the area that burned.She used the heatwraps for approximately 3 to 4 hours and not every day.She reported the product never felt hot, was warm.She wanted to know if the cells had activated.She believes that there was just something wrong with that particular heat wrap, wrap was too hot because she has used thermacare products several times in the past and has never had an issue with them.The patient did not exercise while wearing the heatwrap.She reported reading the usage instructions for the heatwrap before using the product.The patient had previously used other heat products for pain relief (such as electric heating pad, hot water bottle, microwave gel pack) without any issues.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.Therapeutic measures taken included keflex 500mg tablets 3 times daily by mouth for 7 days and silvadene cream applied topically to affected area.No surgical intervention, such as debridement, was required.Clinical outcome of the events open wound, purulent discharge and pain was resolved on an unspecified date in (b)(6) 2017.Clinical outcome of the events third degree burn and blister was resolving.Clinical outcome of the events pruritus and erythema were not resolved.Clinical outcome of the remaining events was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Nurse alleges she got "a third degree burn" from a wrap.The cause of the alleged wrap having "believes that there was just something wrong with that particular heat wrap" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The return sample (lot number: m61533) does not explain why the wrap was too hot.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information received from a contactable nurse included product data (additional device lot number and expiration date).Follow-up ((b)(6) 2017): new information received from the product quality complaints group included investigational results and the additional product complaint from the consumer "believes that there was just something wrong with that particular heat wrap" and the wrap was too hot.Company clinical evaluation comment based on the information provided, the reported events third degree burns, blister, wound, purulent discharge, intentional device misuse, device error and device issue are as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events pain, pruritus, and erythema are assessed as associated with the device use., comment: based on the information provided, the reported events third degree burns, blister, wound, purulent discharge, intentional device misuse, device error and device issue are as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events pain, pruritus, and erythema are assessed as associated with the device use.

Manufacturer Narrative

According to the product quality complaint group as of (b)(6) 2017, the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Nurse alleges she got "a third degree burn" from a wrap.The cause of the alleged wrap having "believes that there was just something wrong with that particular heat wrap" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The return sample (lot number: m61533) does not explain why the wrap was too hot.According to the product quality complaint group as of (b)(6) 2017 regarding lot number: n27782, the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Event verbatim [preferred term] third degree burns [burns third degree] , blistered and open [blister] , blistered and open [wound] , draining yellow discharge [purulent discharge] , applied heatwrap and went to bed; wore more than 2 layers of clothing over the heatwrap [intentional device misuse] , applied heatwrap and went to bed; wore more than 2 layers of clothing over the heatwrap [device use error] , believes that there was just something wrong with that particular heat wrap/wrap was too hot [device issue] , pain [pain] , still read and is itchy at times [pruritus] , still read and is itchy at times [erythema].Case narrative:this is a spontaneous report from a contactable retired nurse reporting on behalf of herself.This (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number: m61533, expiration date: oct2018 also reported as device lot number n27782, expiration date mar2019) from (b)(6) 2017 sporadically as needed for pain.Medical history included neuropathy from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, cervical dystonia from an unknown date and unknown if ongoing (three neck surgeries after car accidents), osteoarthritis from an unknown date and unknown if ongoing, pre-diabetes from an unknown date and unknown if ongoing, chronic pain from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing, eczema from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, acid reflux from an unknown date and unknown if ongoing, irritable bowel from an unknown date and unknown if ongoing, overactive bladder from an unknown date and unknown if ongoing, migraines from an unknown date and unknown if ongoing, anemic from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing, potassium low from an unknown date and unknown if ongoing, fluid retention from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, muscle pain from an unknown date and unknown if ongoing , vitamin d low from an unknown date and unknown if ongoing, gastric bypass surgery (20 plus years ago) from an unknown date and unknown if ongoing, neck surgery from an unknown date and unknown if ongoing (after car accidents; last surgery with rod placement was around 22 years ago), car accident from an unknown date and unknown if ongoing, shingles from an unknown date and unknown if ongoing, sensitive skin from an unknown date and unknown if ongoing, post-menopausal from an unknown date and unknown if ongoing, and skin fissures from an unknown date and unknown if ongoing.Concomitant medications included pregabalin (lyrica) for fibromyalgia from an unspecified date and ongoing, hydrocodone bitartrate, paracetamol (vicodin) for chronic pain from an unspecified date and ongoing, botulinum toxin type a (botox) for migraine and cervical dystonia from an unspecified date and ongoing, omeprazole, sodium bicarbonate (zegerid) for gastrooesophageal reflux disease (gerd) from an unspecified date and ongoing, ranitidine (ranitidine) for acid reflux from an unspecified date and ongoing, cetirizine hydrochloride (zyrtec d) for allergy from an unspecified date and ongoing, potassium chloride (potassium chloride) for potassium low from an unspecified date and ongoing, hydrochlorothiazide (hydrochlorothiazide) for fluid retention from an unspecified date and ongoing, cyanocobalamin (vitamin b12) for anemic from an unspecified date and ongoing, lidocaine (lidoderm) for pain from an unspecified date and ongoing, mometasone furoate (flonase), budesonide for allergy from an unspecified date and ongoing, formoterol fumarate (symbicort) for asthma from an unspecified date and ongoing, salbutamol (albuterol) for asthma from an unspecified date and ongoing, ipratropium bromide, salbutamol sulfate (duoneb) for asthma from an unspecified date and ongoing, epinephrine (epipen) for allergy from an unspecified date and ongoing, montelukast sodium (singulair) for allergy from an unspecified date and ongoing, omeprazole (protonix) for gerd from an unspecified date and ongoing, ondansetron (zofran) for nausea from an unspecified date and ongoing, chlordiazepoxide hydrochloride, clidinium bromide (librax) for irritable bowel from an unspecified date and ongoing, diazepam (valium) for muscle pain from an unspecified date and ongoing, solifenacin succinate (vesicare) for overactive bladder from an unspecified date and ongoing, ergocalciferol (vitamin d) for vitamin d low from an unspecified date and ongoing, butalbital, caffeine, paracetamol (fioricet) for migraine from an unspecified date and ongoing, fluorine and xylitol (biotene) for skin from an unspecified date and ongoing.Past product history included alpha lipoic acid for neuropathy and experienced does not work, neuropathy has still progressed, and kills her stomach; and thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient has used thermacare products for a long time and has never had an issue.On (b)(6) 2017, she applied a thermacare back heatwrap to her back and went to bed.She woke up a few times over the night, adjusted the heatwrap and checked her skin before going back to sleep.She woke up in pain sometime on (b)(6) 2017, after wearing the heatwrap for 3 to 4 hours, and discovered that her entire right hip where the heatwrap was applied was red with a spot slightly larger than a silver dollar that was blistered with an open sore.She initially thought she had shingles, but has already had shingles twice and received the vaccine.She went to an urgent care office and was told by a physician's assistant (pa) she had a third degree burn.By the time she went to the urgent care facility, it was draining yellow discharge in (b)(6) 2017.The patient stated the burn has improved with no more discharge, no open wound and is no longer painful, but it is still red and itchy at times in (b)(6) 2017.She thinks it might leave a scar.The patient mentioned she wore several layers of clothing (wore underwear and her pajamas) over the heatwrap during use and wore a snug waistband/belt or similar or otherwise applied pressure over the area.She no longer has the heatwrap she used to provide as a sample for further investigation.The patient assessed her skin tone as fair.She currently sees a neurologist for neuropathy and a dermatologist for eczema, skin fissures and sensitive skin.The patient mentioned she is on other medications, but nothing that was applied topically to the area that burned.She used the heatwraps for approximately 3 to 4 hours and not every day.She reported the product never felt hot, was warm.She wanted to know if the cells had activated.She believes that there was just something wrong with that particular heat wrap, wrap was too hot because she has used thermacare products several times in the past and has never had an issue with them.The patient did not exercise while wearing the heatwrap.She reported reading the usage instructions for the heatwrap before using the product.The patient had previously used other heat products for pain relief (such as electric heating pad, hot water bottle, microwave gel pack) without any issues.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.Therapeutic measures taken included keflex 500mg tablets 3 times daily by mouth for 7 days and silvadene cream applied topically to affected area.No surgical intervention, such as debridement, was required.Clinical outcome of the events open wound, purulent discharge and pain was resolved on an unspecified date in (b)(6) 2017.Clinical outcome of the events third degree burn and blister was resolving.Clinical outcome of the events pruritus and erythema were not resolved.Clinical outcome of the remaining events was unknown.According to the product quality complaint group as of (b)(6) 2017, the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Nurse alleges she got "a third degree burn" from a wrap.The cause of the alleged wrap having "believes that there was just something wrong with that particular heat wrap" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The return sample (lot number: m61533) does not explain why the wrap was too hot.According to the product quality complaint group as of (b)(6) 2017 regarding lot number: n27782, the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (03feb2017): new information received from a contactable nurse included product data (additional device lot number and expiration date).Follow-up (13mar2017): new information received from the product quality complaints group included investigational results and the additional product complaint from the consumer "believes that there was just something wrong with that particular heat wrap" and the wrap was too hot.Follow-up (27mar2017): follow-up attempts are completed.No further information is expected.Follow-up (06apr2017): new information reported from the product quality complaint group includes: additional investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the reported events third degree burns, blister, wound, purulent discharge, intentional device misuse, device error and device issue are as described in this case are considered serious bodily injuries requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events pain, pruritus, and erythema are assessed as associated with the device use., comment: based on the information provided, the reported events third degree burns, blister, wound, purulent discharge, intentional device misuse, device error and device issue are as described in this case are considered serious bodily injuries requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events pain, pruritus, and erythema are assessed as associated with the device use.

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

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

Manufacturer Contact

b green

235 e42nd street

new york, NY 10017

MDR Report Key

6286411

MDR Text Key

66052980

Report Number

1066015-2017-00021

Device Sequence Number

Product Code

IMD

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

health professional

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup

Report Date

01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Lay User/Patient

Device Expiration Date

10/01/2018

Device Lot Number

M61533; N27782

Was Device Available for Evaluation?

Yes

Is the Reporter a Health Professional?

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

01/30/2017

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided

Supplement Dates FDA Received

02/06/2017
03/20/2017
04/13/2017

Was Device Evaluated by Manufacturer?

Yes

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Treatment

ALBUTEROL; BIOTENE /(B)(4)/; BOTOX; BOTOX; DUONEB; EPIPEN; FIORICET; FLONASE /(B)(4)/; HYDROCHLOROTHIAZIDE; LIBRAX /(B)(4)/; LIDODERM; LYRICA; POTASSIUM CHLORIDE; PROTONIX; RANITIDINE; SINGULAIR; SYMBICORT; VALIUM; VESICARE; VICODIN; VITAMIN B12 /(B)(4)/; VITAMIN B12 /(B)(4)/; VITAMIN D /(B)(4)/; ZEGERID; ZOFRAN /(B)(4)/; ZYRTEC D

Patient Outcome(s)

Required Intervention;

Patient Age

57 YR

Patient Weight

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

Links on this page:

Links on this page: