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

Lot Number S23837

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

Patient Problems Pain (1994); Burn, Thermal (2530); Ambulation Difficulties (2544)

Event Date 07/16/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] got a burn on her back [thermal burn] , can hardly walk [gait disturbance].Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) year-old native american female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot# s23837, expiration date feb2020, upc number: (b)(4), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose since her back was hurting.Medical history included diabetic.Concomitant medications were not reported.Consumer had purchased the product because her back was hurting her.She noticed she got a burn on her back.She had to go to her doctor.It was in such pain.She did not know how she got it.It was hurting her so bad.Her doctor gave her a couple of prescriptions, she needed to go get them.On sunday, (b)(6) 2017 she felt something and had someone check her body.The person told her she got a pretty good burn.Consumer was diabetic and went to her doctor today.They gave her some cream and she would need to go to pharmacy to get cream.She was currently waiting for her son to come home because she could hardly walk.She explained she had never had this happen before.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 "got a burn on her back" as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of "can hardly walk" was assessed as non serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the event of "got a burn on her back" as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of "can hardly walk" was assessed as non serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] got a burn on her back/burn [thermal burn] , one patch overnight and she developed burn on her back (right low back 3cm) [device use error] , can hardly walk [gait disturbance] , itching [pruritus] , cannot sleep at night because it hurts and she cries [insomnia] , cannot sleep at night because it hurts and she cries [crying] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number: s23837, expiration date: feb2020, upc number: 0573301002, via an unspecified route of administration from an unspecified date at unknown dose since her back was hurting.Medical history included diabetic, neuropathy or decreased sensation.No relevant drug history, no drug or alcohol abuse.There were none concomitant medications.Consumer had purchased the product because her back was hurting her.She noticed she got a burn on her back.She had to go to her doctor.It was in such pain.She did not know how she got it.It was hurting her so bad.Her doctor gave her a couple of prescriptions, she needed to go get them.On sunday, (b)(6) 2017 she felt something and had someone check her body.The person told her she got a pretty good burn.One patch overnight and she developed burn on her back (right low back 3cm).Consumer was diabetic and went to her doctor today.They gave her some cream and she would need to go to pharmacy to get cream.She was currently waiting for her son to come home because she could hardly walk.She explained she had never had this happen before.The patient further reported she got a burn on her back.Stated the burn was getting better because it was itching in 2017.Stated she just wanted the itching to get better.However, she could not sleep at night because it hurt and she cried.Initially the burn was really bad and she went to the doctor.Stated her doctor gave her a form to fill out to send back to us and she will mail it.Treatment: the doctor gave her cream, but she ran out of it.She had to go back to the doctor to get more cream.The doctor gave her mupirocin ointment usp 2% ointment to place on her back and cover with a band-aid.The treatment also included silvadane cream to affected area once day as needed.Stated if she wore clothes she had to watch what she wear so it did not rub against it, had to be careful with underwear so it did not go right over it.No surgical intervention was required.No lab tested required.The patient was not hospitalized for the event burn on her back.The action taken in response to the events of the product was unknown.The outcome of the event burn was recovering, itching was not recovered, other events outcome was unknown.The physician considered there was a reasonable possibility that the event was related to suspect device.Additional information has been requested and will be provided as it becomes available.Follow-up (03aug2017): new information received from a contactable consumer included: new events information and events outcome.Follow-up (08aug2017): new information received from a contactable physician includes: medical history, no concomitant medications, more event treatment, added new event "one patch overnight and she developed burn on her back (right low back 3cm)", causality assessment.The patient was not hospitalized for the event "burn on her back".Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the event of "got a burn on her back" "one patch overnight " as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of "can hardly walk" "itching" "cannot sleep at night because it hurt and she cried" were assessed as non serious.The events are medically assessed as associated with the use of the device.In the case narrative there is evidence of device use error "one patch overnight " which most likely contributed to this incident., comment: based on the information provided, the event of "got a burn on her back" "one patch overnight " as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of "can hardly walk" "itching" "cannot sleep at night because it hurt and she cried" were assessed as non serious.The events are medically assessed as associated with the use of the device.In the case narrative there is evidence of device use error "one patch overnight " which most likely contributed to this incident.

Event Description

Event verbatim [preferred term] got a burn on her back/burn [thermal burn], can hardly walk [gait disturbance], itching [pruritus], cannot sleep at night because it hurts and she cries [insomnia], cannot sleep at night because it hurts and she cries [crying].Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) native american female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot# s23837, expiration date feb2020, upc number: (b)(4), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose since her back was hurting.Medical history included diabetic.Concomitant medications were not reported.Consumer had purchased the product because her back was hurting her.She noticed she got a burn on her back.She had to go to her doctor.It was in such pain.She did not know how she got it.It was hurting her so bad.Her doctor gave her a couple of prescriptions, she needed to go get them.On (b)(6) 2017 she felt something and had someone check her body.The person told her she got a pretty good burn.Consumer was diabetic and went to her doctor today.They gave her some cream and she would need to go to pharmacy to get cream.She was currently waiting for her son to come home because she could hardly walk.She explained she had never had this happen before.The patient further reported she got a burn on her back.Stated the burn was getting better because it was itching.Stated she just wanted the itching to get better.However, she cannot sleep at night because it hurt and she cried.Initially the burn was really bad and she went to the doctor.Stated her doctor gave her a form to fill out to send back to us and she will mail it.Treatment: the doctor gave her cream, but she ran out of it.She had to go back to the doctor to get more cream.The doctor gave her mupirocin ointment usp 2% ointment to place on her back and cover with a band-aid.Stated if she wear clothes she had to watch what she wear so it did not rub against it, had to be careful with underwear so it did not go right over it.The action taken in response to the events of the product was unknown.The outcome of the event burn was recovering, itching was not recovered, other events outcome was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (03aug2017): new information received from a contactable consumer included: new events information and events outcome.Company clinical evaluation comment: based on the information provided, the event of "got a burn on her back" as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of "can hardly walk" "itching" "cannot sleep at night because it hurt and she cried" was assessed as non serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the event of "got a burn on her back" as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of "can hardly walk" was assessed as 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).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

Got a burn on her back/burn [thermal burn] , one patch overnight and she developed burn on her back (right low back 3 cm) [device use error] , can hardly walk [gait disturbance] , itching [pruritus] , cannot sleep at night because it hurts and she cries [insomnia] , cannot sleep at night because it hurts and she cries [crying] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) female patient started to use thermacare heatwrap (thermacare lower back and hip) (device lot number: s23837, expiration date: feb2020, (b)(4)) from an unspecified date since her back was hurting.Medical history included diabetic, neuropathy or decreased sensation.No relevant drug history, no drug or alcohol abuse.There were none concomitant medications.Consumer had purchased the product because her back was hurting her.She noticed she got a burn on her back.She had to go to her doctor.It was in such pain.She did not know how she got it.It was hurting her so bad.Her doctor gave her a couple of prescriptions, she needed to go get them.On sunday, (b)(6) 2017 she felt something and had someone check her body.The person told her she got a pretty good burn.One patch overnight and she developed burn on her back (right low back 3 cm).Consumer was diabetic and went to her doctor today.They gave her some cream and she would need to go to pharmacy to get cream.She was currently waiting for her son to come home because she could hardly walk.She explained she had never had this happen before.The patient further reported she got a burn on her back.Stated the burn was getting better because it was itching in 2017.Stated she just wanted the itching to get better.However, she could not sleep at night because it hurt and she cried.Initially the burn was really bad and she went to the doctor.Stated her doctor gave her a form to fill out to send back to us and she will mail it.Treatment: the doctor gave her cream, but she ran out of it.She had to go back to the doctor to get more cream.The doctor gave her mupirocin ointment usp 2% ointment to place on her back and cover with a band-aid.The treatment also included silvadene cream to affected area once day as needed.Stated if she wore clothes she had to watch what she wear so it did not rub against it, had to be careful with underwear so it did not go right over it.No surgical intervention was required.No lab tested required.The patient was not hospitalized for the event burn on her back.The action taken in response to the events of the product was unknown.The outcome of the event burn was recovering, itching was not recovered, other events outcome was unknown.The physician considered there was a reasonable possibility that the event was related to suspect device.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 (03aug2017): new information received from a contactable consumer included: new events information and events outcome.Follow-up (08aug2017): new information received from a contactable physician includes: medical history, no concomitant medications, more event treatment, added new event "one patch overnight and she developed burn on her back (right low back 3 cm)", causality assessment.The patient was not hospitalized for the event "burn on her back".Follow-up attempts are completed.No further information is expected.Follow-up (23aug2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment: based on the information provided, the event of "got a burn on her back" "one patch overnight " as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of "can hardly walk" "itching" "cannot sleep at night because it hurt and she cried" were assessed as non serious.The events are medically assessed as associated with the use of the device.In the case narrative there is evidence of device use error "one patch overnight " which most likely contributed to this incident., comment: based on the information provided, the event of "got a burn on her back" "one patch overnight " as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The reported event of "can hardly walk" "itching" "cannot sleep at night because it hurt and she cried" were assessed as non serious.The events are medically assessed as associated with the use of the device.In the case narrative there is evidence of device use error "one patch overnight " which most likely contributed to this incident.

• 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: 6731758
• MDR Text Key: 80668594
• Report Number: 1066015-2017-00121
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/18/2017

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: 02/01/2020
• Device Lot Number: S23837
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/14/2017; 08/14/2017; 08/28/2017
• 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: 77 YR
• Patient Weight: 52