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

Lot Number S23842

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Full thickness (Third Degree) Burn (2696)

Event Date 07/18/2017

Event Type  Injury  

Event Description

The 3rd degree burns/the burns located on the lower back [burns third degree] , did not check the skin under the product while wearing the wrap, did not think she needed to [intentional device misuse] , did not check the skin under the product while wearing the wrap, did not think she needed to [device use error] , just the burns and infected [burn infection] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) on (b)(6) 2017 one time for 7-8 hours for back pain.Medical history included hypertension from an unknown date and unknown if ongoing.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2017, the patient reported she used the heatwrap for 7-8 hours and used the heatwrap correctly and experienced 3rd degree burns located on the lower back.She stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to, it wasn't bothering her.On (b)(6) 2017, she went to work and noticed her shirt was wet and her chair was wet.She asked a coworker to look and see what was going on with her back and was told she had big, huge blisters on her back.She asked the coworker to put caller's hand on the blisters she saw and that's when she found out there was a problem.She went to the doctor on (b)(6) 2017 and was told to use silver sulfadiazine.She went back to the doctor on (b)(6) 2017 and showed her doctor and was told it wasn't getting better.The doctor said she had to go to a wound care specialist.She went to the wound care specialist on (b)(6) 2017 and they had to scrape it.She goes back again on (b)(6) 2017 and the rest of the scraping will be done then.They are severe, deep third degree burns.The patient reported she knows she will have permanent scarring.She stated she had huge blisters on her back, two blisters the size of half dollars and two that are the size of quarters.On an unspecified date, the patient reported the burns were infected.The patient assessed her skin tone as medium (neither light nor dark).She is currently under the care of a physician for her high blood pressure, "just the typical stuff".The patient denied having sensitive skin or any abnormal skin conditions.She stated she used a heating pad in the past for pain relief but it did not do anything like this.The patient read the usage instructions prior to using the product.She did not engage in exercise while wearing the heatwrap.The patient was not taking any medications (including over-the-counter, herbal nutritional or any applied to the skin) during the time the events were experienced.She stated she wore the heatwrap on her body, wrapping it around her attaching it to itself.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.Therapeutic measures taken included special packing and silver sulfadiazine.Clinical outcome of the events 3rd degree burns and burn blisters was not resolved.Clinical outcome of the events burn infection device use error 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 events of " 3rd degree burns ", " burn infection", "she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to" 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.In the case narrative there is evidence of device use error (she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to) which most likely contributed to this incident., comment: based on the information provided, the events of " 3rd degree burns ", " burn infection", "she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to" 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.In the case narrative there is evidence of device use error (she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to) which most likely contributed to this incident.

Event Description

Event verbatim [preferred term] 3rd degree burns/the burns located on the lower back [burns third degree] , just the burns and infected/she also has an infection [burn infection] , did not check the skin under the product while wearing the wrap, did not think she needed to [intentional device misuse] , did not check the skin under the product while wearing the wrap, did not think she needed to [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) lot number: s23842, expiry date: mar2020, upc number: 305733010037, on (b)(6) 2017 one time for 7-8 hours for back pain.Medical history included hypertension from an unknown date and unknown if ongoing.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2017, the patient reported she used the heatwrap for 7-8 hours and used the heatwrap correctly and experienced 3rd degree burns located on the lower back.She stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to, it wasn't bothering her.On (b)(6) 2017, she went to work and noticed her shirt was wet and her chair was wet.She asked a coworker to look and see what was going on with her back and was told she had big, huge blisters on her back.She asked the coworker to put caller's hand on the blisters she saw and that's when she found out there was a problem.She went to the doctor on (b)(6) 2017 and was told to use silver sulfadene.She went back to the doctor on (b)(6) 2017 and showed her doctor and was told it wasn't getting better.The doctor said she had to go to a wound care specialist.She went to the wound care specialist on (b)(6) 2017 and they had to scrape it.She goes back again on (b)(6) 2017 and the rest of the scraping will be done then.They are severe, deep third degree burns.The patient reported she knows she will have permanent scarring.She stated she had huge blisters on her back, two blisters the size of half dollars and two that are the size of quarters.On an unspecified date, the patient reported the burns were infected.The patient assessed her skin tone as medium (neither light nor dark).She is currently under the care of a physician for her high blood pressure, "just the typical stuff".The patient denied having sensitive skin or any abnormal skin conditions.She stated she used a heating pad in the past for pain relief but it did not do anything like this.The patient read the usage instructions prior to using the product.She did not engage in exercise while wearing the heatwrap.The patient was not taking any medications (including over-the-counter, herbal nutritional or any applied to the skin) during the time the events were experienced.She stated she wore the heatwrap on her body, wrapping it around her attaching it to itself.As of (b)(6) 2017, consumer reported that she used the product as directed and now had severe deep 3rd degree burns.There were 2 wraps in the pack and she only used 1.She had to go to wound care for scraping.She went last thursday and had to go back next thursday.She also had an infection and was on antibiotics.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.Therapeutic measures taken included special packing, silver sulfadene and antibiotics.Clinical outcome of the events 3rd degree burns and burn blisters was not resolved.Clinical outcome of the events burn infection device use error was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (01aug2017): new information received from a contactable consumer included: suspect product data (lot#, expiration date), treatment received.Company clinical evaluation comment: based on the information provided, the events of " 3rd degree burns ", " burn infection", "she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to" 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.In the case narrative there is evidence of device use error (she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to) which most likely contributed to this incident., comment: based on the information provided, the events of " 3rd degree burns ", " burn infection", "she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to" 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.In the case narrative there is evidence of device use error (she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to) which most likely contributed to this incident.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).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.Evaluation of the consumers' return sample did not provide any additional information as to why the wrap would cause a burn; the alleged defective wrap worn by consumer was not returned.The plant has reviewed this batch from a manufacturing and technical 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.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] 3rd degree burns/the burns located on the lower back [burns third degree] , just the burns and infected/she also has an infection [burn infection] , did not check the skin under the product while wearing the wrap, did not think she needed to/ the patient read the usage instructions prior to using the product [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) -year-old caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip) lot number: s23842, expiry date: (b)(6) 2020, upc number: (b)(4), on (b)(6) 2017 one time for 7-8 hours for back pain.Medical history included hypertension from an unknown date and unknown if ongoing.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2017, the patient reported she used the heatwrap for 7-8 hours and used the heatwrap correctly and experienced 3rd degree burns located on the lower back.She stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to, it wasn't bothering her.On 19jul2017, she went to work and noticed her shirt was wet and her chair was wet.She asked a coworker to look and see what was going on with her back and was told she had big, huge blisters on her back.She asked the coworker to put caller's hand on the blisters she saw and that's when she found out there was a problem.She went to the doctor on (b)(6) 2017 and was told to use silver sulfadene.She went back to the doctor on (b)(6) 2017 and showed her doctor and was told it wasn't getting better.The doctor said she had to go to a wound care specialist.She went to the wound care specialist on (b)(6) 2017 and they had to scrape it.She goes back again on (b)(6) 2017 and the rest of the scraping will be done then.They are severe, deep third degree burns.The patient reported she knows she will have permanent scarring.She stated she had huge blisters on her back, two blisters the size of half dollars and two that are the size of quarters.On an unspecified date, the patient reported the burns were infected.The patient assessed her skin tone as medium (neither light nor dark).She is currently under the care of a physician for her high blood pressure, "just the typical stuff".The patient denied having sensitive skin or any abnormal skin conditions.She stated she used a heating pad in the past for pain relief but it did not do anything like this.The patient read the usage instructions prior to using the product.She did not engage in exercise while wearing the heatwrap.The patient was not taking any medications (including over-the-counter, herbal nutritional or any applied to the skin) during the time the events were experienced.She stated she wore the heatwrap on her body, wrapping it around her attaching it to itself.As of (b)(6) 2017, consumer reported that she used the product as directed and now had severe deep 3rd degree burns.There were 2 wraps in the pack and she only used 1.She had to go to wound care for scraping.She went last thursday and had to go back next thursday.She also had an infection and was on antibiotics.Action taken with the suspect product was permanently withdrawn on 18jul2017.Therapeutic measures taken included special packing, silver sulfadene and antibiotics.Clinical outcome of the events 3rd degree burns and burn blisters was not resolved.Clinical outcome of the events burn infection device use error was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).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.Evaluation of the consumers' return sample did not provide any additional information as to why the wrap would cause a burn; the alleged defective wrap worn by consumer was not returned.The plant has reviewed this batch from a manufacturing and technical 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.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 017): new information received from a contactable consumer included: suspect product data (lot#, expiration date), treatment received.Follow-up ((b)(6) 2017): new information received from product quality complaints (pqc) group included: updated suspect product expiration date and provided product quality investigation results.Removed event of device use error.Company clinical evaluation comment based on the information provided, the events of " 3rd degree burns ", " burn infection", "she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to/ the patient read the usage instructions prior to using the product" 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., comment: based on the information provided, the events of " 3rd degree burns ", " burn infection", "she stated she did not check the skin under the product while wearing the heatwrap as she didn't think she needed to/ the patient read the usage instructions prior to using the product" 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.

• 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: 6762969
• MDR Text Key: 81686140
• Report Number: 1066015-2017-00128
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Lot Number: S23842
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/04/2017; 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 113