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

Lot Number T48910

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

Patient Problems Erythema (1840); Pain (1994); Sleep Dysfunction (2517); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)

Event Date 01/22/2019

Event Type  Injury  

Event Description

Event verbatim (preferred term) huge elongated wide and thick bubble which had formed in the lower and middle area of my back as well as two smaller bubbles on the right and on the left (burns second degree), movement restricted (movement disorder), restless to sleepless night (insomnia).Case narrative:this is a spontaneous report from a pfizer-sponsored program selbstmedikation from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (thermacare heatwrap) lot number t48910, expiration date 09jan2020, from unknown date for pulled a muscle in the lower back right.Medical history included coughing attack, laryngitis and fever.Concomitant medications were not reported.The patient applied a heatwrap around the lower back on monday evening, (b)(6) 2019, around 9:00 pm.At a coughing attack she pulled a muscle in the lower back right.On tuesday morning she removed the heat wrap but her lower back area weakened and burned.A short side glance into the mirror showed a redness in named area.This condition accompanies her throughout the day until the next night and made for a restless to sleepless night.She startled then, as she felt a bead in her lower back that was clearly no fat.It was a matter of a huge elongated wide and thick bubble which had formed in the lower and middle area of her back as well as two smaller bubbles on the right and on the left.With severe pain and movement restrictions she went to her general practice immediately at practice opening yesterday morning ((b)(6) 2019).Her treating physician had to open the big bubble, make wound care and provide the wound with appropriate patches.In pain, she went back home, where she spent the day sitting half-way, sparing the lower back area.She had to undergo the same procedure again today ((b)(6) 2019).For tomorrow is another visit to the doctor planned.Her arranged bed rest due to her laryngitis accompanied by fever and irritating coughing did not improved by the pain in the back and the daily visits to the doctor.She cannot express her disappointment, her horror, her hock and is not able all to express her pain in words.Last week she used a neck wrap.This helped her without problems.Back then the heatwraps were recommended to her from her cousin, the physiotherapist, since the abc plaster stuck extremely.She knew the heatwraps for years, no matter in what form and always tolerated them well.But now she was just stunned.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events movement restricted and restless to sleepless night are non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events movement restricted and restless to sleepless night are non-serious.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

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 a burn/blister from wrap.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] huge elongated wide and thick bubble which had formed in the lower and middle area of my back as well as two smaller bubbles on the right and on the left [burns second degree] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program selbstmedikation from a contactable consumer.This 44-year-old female patient started to use thermacare heatwrap (thermacare heatwrap) (device lot number t48910, expiration date 09jan2020) from an unknown date for pulled a muscle in the lower back right.Medical history included coughing attack, laryngitis and fever.Concomitant medications were not reported.The patient applied a heatwrap around the lower back on monday evening, (b)(6) 2019, around 9:00 pm.At a coughing attack she pulled a muscle in the lower back right.On tuesday morning ((b)(6) 2019), she removed the heatwrap but her lower back area weakened and burned.A short side glance into the mirror showed a redness in named area.This condition accompanies her throughout the day until the next night and made for a restless to sleepless night.She startled then, as she felt a bead in her lower back that was clearly no fat.It was a matter of a huge elongated wide and thick bubble which had formed in the lower and middle area of her back as well as two smaller bubbles on the right and on the left.With severe pain and movement restrictions (on (b)(6) 2019) she went to her general practice immediately at practice opening yesterday morning (on (b)(6) 2019).Her treating physician had to open the big bubble, make wound care and provide the wound with appropriate patches.In pain, she went back home, where she spent the day sitting half-way, sparing the lower back area.She had to undergo the same procedure again today ((b)(6) 2019).For tomorrow is another visit to the doctor planned.Her arranged bed rest due to her laryngitis accompanied by fever and irritating coughing did not improved by the pain in the back and the daily visits to the doctor.She cannot express her disappointment, her horror, her hock and is not able all to express her pain in words.Last week she used a neck wrap.This helped her without problems.Back then the heatwraps were recommended to her from her cousin, the physiotherapist, since the abc plaster stuck extremely.She knew the heatwraps for years, no matter in what form and always tolerated them well.But now she was just stunned.Upon follow-up received on 01feb2019 from the regulatory authority bfarm (regulatory authority report number (b)(4) patient age was reported.Action taken in response to the events of the product was unknown.The outcome of the events was unknown.On follow-up 22feb2019, product complaint group provided following investigational report for lot t48910: batch t48910 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.Form-(b)(4) retain sample inspection form documented the retain evaluation performed on (b)(6) 2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request for investigation received at the 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 per spec-28881, effective: 08-jun-2017.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports a burn/blister from wrap.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 (01feb2019): new information received from the bfarm (ra) includes: patient age.Follow-up (22feb2019): new information received from product complaint group includes: investigational report for lot t48910, and investigation summary., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event burn second degree is medically assessed as associated with the use of the device.The events movement restricted and restless to sleepless night are non-serious and attributed to the burn but 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.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Huge elongated wide and thick bubble which had formed in the lower and middle area of my back as well as two smaller bubbles on the right and on the left [burns second degree], movement restricted [movement disorder], restless to sleepless night [insomnia].Case narrative: this is a spontaneous report from a pfizer-sponsored program selbstmedikation from a contactable consumer and also received from bfarm (ra).This 44-year-old female consumer started to receive thermacare heatwrap (thermacare heatwrap) lot number: t48910, expiration date: 09jan2020, from unknown date for pulled a muscle in the lower back right.Medical history included coughing attack, laryngitis and fever.Concomitant medications were not reported.The patient applied a heatwrap around the lower back on monday evening, on (b)(6) 2019, around 9:00 pm.At a coughing attack she pulled a muscle in the lower back right.On tuesday morning (on (b)(6) 2019) she removed the heat wrap but her lower back area weakened and burned.A short side glance into the mirror showed a redness in named area.This condition accompanies her throughout the day until the next night and made for a restless to sleepless night.She startled then, as she felt a bead in her lower back that was clearly no fat.It was a matter of a huge elongated wide and thick bubble which had formed in the lower and middle area of her back as well as two smaller bubbles on the right and on the left.With severe pain and movement restrictions (on (b)(6) 2019) she went to her general practice immediately at practice opening yesterday morning (on (b)(6) 2019).Her treating physician had to open the big bubble, make wound care and provide the wound with appropriate patches.In pain, she went back home, where she spent the day sitting half-way, sparing the lower back area.She had to undergo the same procedure again today (on (b)(6) 2019).For tomorrow is another visit to the doctor planned.Her arranged bed rest due to her laryngitis accompanied by fever and irritating coughing did not improved by the pain in the back and the daily visits to the doctor.She cannot express her disappointment, her horror, her hock and is not able all to express her pain in words.Last week she used a neck wrap.This helped her without problems.Back then the heatwraps were recommended to her from her cousin, the physiotherapist, since the abc plaster stuck extremely.She knew the heatwraps for years, no matter in what form and always tolerated them well.But now she was just stunned.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (01feb2019): new information received from the bfarm (ra) includes: patient age.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events movement restricted and restless to sleepless night are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events movement restricted and restless to sleepless night are non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] huge elongated wide and thick bubble which had formed in the lower and middle area of my back as well as two smaller bubbles on the right and on the left [burns second degree] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program selbstmedikation from a contactable consumer.This 44-year-old female patient started to use thermacare heatwrap (thermacare heatwrap) (device lot number t48910, expiration date 09jan2020) from an unknown date for pulled a muscle in the lower back right.Medical history included coughing attack, laryngitis and fever.Concomitant medications were not reported.The patient applied a heatwrap around the lower back on monday evening, 21jan2019, around 9:00 pm.At a coughing attack she pulled a muscle in the lower back right.On tuesday morning (22jan2019), she removed the heatwrap but her lower back area weakened and burned.A short side glance into the mirror showed a redness in named area.This condition accompanies her throughout the day until the next night and made for a restless to sleepless night.She startled then, as she felt a bead in her lower back that was clearly no fat.It was a matter of a huge elongated wide and thick bubble which had formed in the lower and middle area of her back as well as two smaller bubbles on the right and on the left.With severe pain and movement restrictions (jan2019) she went to her general practice immediately at practice opening yesterday morning (23jan2019).Her treating physician had to open the big bubble, make wound care and provide the wound with appropriate patches.In pain, she went back home, where she spent the day sitting half-way, sparing the lower back area.She had to undergo the same procedure again today (24jan2019).For tomorrow is another visit to the doctor planned.Her arranged bed rest due to her laryngitis accompanied by fever and irritating coughing did not improved by the pain in the back and the daily visits to the doctor.She cannot express her disappointment, her horror, her hock and is not able all to express her pain in words.Last week she used a neck wrap.This helped her without problems.Back then the heatwraps were recommended to her from her cousin, the physiotherapist, since the abc plaster stuck extremely.She knew the heatwraps for years, no matter in what form and always tolerated them well.But now she was just stunned.Upon follow-up received on 01feb2019 from the regulatory authority bfarm (regulatory authority report number 00965/19), patient age was reported.Action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (01feb2019): new information received from the bfarm (ra) includes: patient age.Company clinical evaluation comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event burn second degree is medically assessed as associated with the use of the device.The events movement restricted and restless to sleepless night are non-serious and attributed to the burn but not associated with the use of the device., comment: based on the information provided, the event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event burn second degree is medically assessed as associated with the use of the device.The events movement restricted and restless to sleepless night are non-serious and attributed to the burn but not associated with the use of the device.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8285384
• MDR Text Key: 134598853
• Report Number: 1066015-2019-00023
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2020
• Device Lot Number: T48910
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/06/2019; 02/07/2019; 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR