|
|
| Lot Number CN9707 |
| Device Problems
Overheating of Device (1437); Use of Device Problem (1670); Excessive Heating (4030)
|
| Patient Problems
Pain (1994); Burning Sensation (2146); Burn, Thermal (2530)
|
| Event Date 02/28/2020 |
|
Event Type
Injury
|
|
Event Description
|
|
It burned her skin/she had 3 huge almost open wounds on her lower back/ kind of puffy and really painful and kind of hot like you get a burn and it was radiating heat/ burning sensation [burns second degree] , it was almost like the product was defective because it only burned her right side on 3 areas [device issue] , she had sciatica and sometimes it acted up and it really helped [intentional device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number cn9707, expiration date aug2022, via an unspecified route of administration from (b)(6) 2020 to an unspecified date at an unknown dose for sciatica.Medical history and concomitant medications were none.The patient stated she purchased a 2 package box and used once and it helped really well.She stated a couple of days later, she had sciatica and sometimes it acted up and it really helped on (b)(6) 2020.She stated her sciatica acted up and sometimes it was hard for her to stand up and walk.She said heat improved muscle relaxation.She used to take medication for it and she did not like pills, so she stopped.The patient stated the first one worked great and she said it lasted for several days and she had a lot of pain, so she used the second one.She stated this time within just a couple of hours, it burned her skin and it had been 4 days and she had 3 huge almost open wounds on her lower back on (b)(6) 2020.She didn't know what to do.She stated it was still really painful.She took pictures.She didn't want this to happen to her or anyone else again.She didn't know if she should contact a lawyer or go through a doctor.The patient stated the first time she looked at the burn, it was raised and not a complete blister, clarifying it was kind of puffy and really painful and kind of hot like you got a burn and it was radiating heat.She had underwear on and pajama shorts and she put the wrap over both of those because she was (b)(6) and it said if you are over 55 you need to wear something under it.She did not really notice it was burned until she took it off.It felt warm but it did not feel like it was burning her.She was really shocked.She thought, "what the heck, why is it so bad?" she touched it and it was very painful.The patient worked in administration in a hospital for 18 years and she worked with pfizer products with the hospital and subspecialty departments and there really had been good products.She stated her weight was between 175-180 lb.She did not have a primary care physician, because it was a teaching hospital that she worked at.She stated she could see how raw and red it was.She stated there were 3 burns on right side, clarifying it was almost like the product was defective because it only burned her right side on 3 areas.The left side was nothing.She could not determine the outcome and stated that when you touch it, it was still hot, but the burning sensation had improved a little bit.It was not completely gone.She had to be careful when she pulled underwear up.She could not have elastic near that.It irritated it.She stated she took aleve for that.The patient said she did not want to go to the doctor.She said it was a burn and she treated it as a burn.She worked in burn unit for 6 years.She knew how to treat it and was able to help herself.Unless she needed to for legal department, she would continue to try and take care of it herself.She stated she needed to get her glasses to read package.She did not indicate if she needed glasses prior to using product.She provided (b)(6) 2023 at the end of lot number.The time stamp after that is 22:07.The product was a size small/medium and she did retain the product.She stated she would probably have scars for the rest of her life to her backside.She said without it healing, she wouldn't know how big the scars were, clarifying anytime you get a burn, they scar.She said it could have been a malfunction.She had seen many in the burn center where she worked have scars for the rest of their lives.The patient considered that there is a reasonable possibility that the events burns and permanent scarring were related to the device.She stated sometimes when you had a scar, it was sensitive to touch for years.She said if there wasn't a qa department to spot check this type of heat wrap, that there definitely should be.This was defective.She said she would retain the device but was unsure if she would be willing to send it back until she spoke with an attorney.They might suggest she keep it for a while.The last action taken in response to events for thermacare heatwrap was permanently withdrawn in (b)(6) 2020.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the complaints of "burns second degree from alleged device issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Intentional device use issue was assessed as non-serious.A causal relationship between the device and complaints cannot be ruled out.
|
| |
|
Manufacturer Narrative
|
|
Site sample status was not received.Batch: cn9707 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: 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 wrap "kind of hot." the cause of the consumer reporting wrap being "kind of hot¿ is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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.Root cause/capa process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of wrap/patch/pad too hot for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of wrap/patch/pad too hot for lbh product, refer to attachment wrap patch pad too hot (initials) 09mar2017 to 09mar2020.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.
|
| |
|
Event Description
|
|
It burned her skin/she had 3 huge almost open wounds on her lower back/ kind of puffy and really painful and kind of hot like you get a burn and it was radiating heat/ burning sensation [burns second degree], it was almost like the product was defective because it only burned her right side on 3 areas [device issue], she had sciatica and sometimes it acted up and it really helped [intentional device use issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A 56-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: cn9707, expiration date: aug2022, via an unspecified route of administration from on (b)(6) 2020 to an unspecified date at an unknown dose for sciatica.Medical history and concomitant medications were none.The patient stated she purchased a 2 package box and used once and it helped really well.She stated a couple of days later, she had sciatica and sometimes it acted up and it really helped on (b)(6) 2020.She stated her sciatica acted up and sometimes it was hard for her to stand up and walk.She said heat improved muscle relaxation.She used to take medication for it and she did not like pills, so she stopped.The patient stated the first one worked great and she said it lasted for several days and she had a lot of pain, so she used the second one.She stated this time within just a couple of hours, it burned her skin and it had been 4 days and she had 3 huge almost open wounds on her lower back on (b)(6) 2020.She didn't know what to do.She stated it was still really painful.She took pictures.She didn't want this to happen to her or anyone else again.She didn't know if she should contact a lawyer or go through a doctor.The patient stated the first time she looked at the burn, it was raised and not a complete blister, clarifying it was kind of puffy and really painful and kind of hot like you got a burn and it was radiating heat.She had underwear on and pajama shorts and she put the wrap over both of those because she was 56 and it said if you are over 55 you need to wear something under it.She did not really notice it was burned until she took it off.It felt warm but it did not feel like it was burning her.She was really shocked.She thought, "what the heck, why is it so bad?" she touched it and it was very painful.The patient worked in administration in a hospital for 18 years and she worked with pfizer products with the hospital and subspecialty departments and there really had been good products.She stated her weight was between 175-180 lb.She did not have a primary care physician, because it was a teaching hospital that she worked at.She stated she could see how raw and red it was.She stated there were 3 burns on right side, clarifying it was almost like the product was defective because it only burned her right side on 3 areas.The left side was nothing.She could not determine the outcome and stated that when you touch it, it was still hot, but the burning sensation had improved a little bit.It was not completely gone.She had to be careful when she pulled underwear up.She could not have elastic near that.It irritated it.She stated she took aleve for that.The patient said she did not want to go to the doctor.She said it was a burn and she treated it as a burn.She worked in burn unit for 6 years.She knew how to treat it and was able to help herself.Unless she needed to for legal department, she would continue to try and take care of it herself.She stated she needed to get her glasses to read package.She did not indicate if she needed glasses prior to using product.She provided on (b)(6) 2023 at the end of lot number.The time stamp after that is 22:07.The product was a size small/medium and she did retain the product.She stated she would probably have scars for the rest of her life to her backside.She said without it healing, she wouldn't know how big the scars were, clarifying anytime you get a burn, they scar.She said it could have been a malfunction.She had seen many in the burn center where she worked have scars for the rest of their lives.The patient considered that there is a reasonable possibility that the events burns and permanent scarring were related to the device.She stated sometimes when you had a scar, it was sensitive to touch for years.She said if there wasn't a qa department to spot check this type of heat wrap, that there definitely should be.This was defective.She said she would retain the device but was unsure if she would be willing to send it back until she spoke with an attorney.They might suggest she keep it for a while.The last action taken in response to events for thermacare heatwrap was permanently withdrawn in mar2020.The outcome of the events was unknown.According to the product quality complaint group: reasonably suggest device malfunction was yes and severity of harm was s3 for subclass adverse event/serious/unknown and wrap/patch/pad too hot.Site sample status was not received.Batch: cn9707 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: 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 wrap "kind of hot." the cause of the consumer reporting wrap being "kind of hot" is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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.Root cause/capa process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of wrap/patch/pad too hot for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of wrap/patch/pad too hot for lbh product, refer to attachment wrap patch pad too hot (initials) 09mar2017 to 09mar2020.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Follow-up (18mar2020): new information received from product quality complaint group includes investigation results.Follow-up (23apr2020): new information received from a product complaint group included: severity of harm and malfunction assessment.Follow-up (09may2020): follow-up attempts are completed.No further information is expected.Follow-up (13oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] it burned her skin/she had 3 huge almost open wounds on her lower back/ kind of puffy and really painful and kind of hot like you get a burn and it was radiating heat/ burning sensation [burns second degree] , it was almost like the product was defective because it only burned her right side on 3 areas [device issue] , she had sciatica and sometimes it acted up and it really helped [intentional device use issue].Case narrative:this is a spontaneous report from a contactable consumer (patient).A 56-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number cn9707, expiration date aug2022, via an unspecified route of administration from (b)(6) 2020 to an unspecified date at an unknown dose for sciatica.Medical history and concomitant medications were none.The patient stated she purchased a 2 package box and used once and it helped really well.She stated a couple of days later, she had sciatica and sometimes it acted up and it really helped on (b)(6) 2020.She stated her sciatica acted up and sometimes it was hard for her to stand up and walk.She said heat improved muscle relaxation.She used to take medication for it and she did not like pills, so she stopped.The patient stated the first one worked great and she said it lasted for several days and she had a lot of pain, so she used the second one.She stated this time within just a couple of hours, it burned her skin and it had been 4 days and she had 3 huge almost open wounds on her lower back on (b)(6) 2020.She didn't know what to do.She stated it was still really painful.She took pictures.She didn't want this to happen to her or anyone else again.She didn't know if she should contact a lawyer or go through a doctor.The patient stated the first time she looked at the burn, it was raised and not a complete blister, clarifying it was kind of puffy and really painful and kind of hot like you got a burn and it was radiating heat.She had underwear on and pajama shorts and she put the wrap over both of those because she was 56 and it said if you are over 55 you need to wear something under it.She did not really notice it was burned until she took it off.It felt warm but it did not feel like it was burning her.She was really shocked.She thought, "what the heck, why is it so bad?" she touched it and it was very painful.The patient worked in administration in a hospital for 18 years and she worked with pfizer products with the hospital and subspecialty departments and there really had been good products.She stated her weight was between 175-180 lb.She did not have a primary care physician, because it was a teaching hospital that she worked at.She stated she could see how raw and red it was.She stated there were 3 burns on right side, clarifying it was almost like the product was defective because it only burned her right side on 3 areas.The left side was nothing.She could not determine the outcome and stated that when you touch it, it was still hot, but the burning sensation had improved a little bit.It was not completely gone.She had to be careful when she pulled underwear up.She could not have elastic near that.It irritated it.She stated she took aleve for that.The patient said she did not want to go to the doctor.She said it was a burn and she treated it as a burn.She worked in burn unit for 6 years.She knew how to treat it and was able to help herself.Unless she needed to for legal department, she would continue to try and take care of it herself.She stated she needed to get her glasses to read package.She did not indicate if she needed glasses prior to using product.She provided (b)(6) 2023 at the end of lot number.The time stamp after that is 22:07.The product was a size small/medium and she did retain the product.She stated she would probably have scars for the rest of her life to her backside.She said without it healing, she wouldn't know how big the scars were, clarifying anytime you get a burn, they scar.She said it could have been a malfunction.She had seen many in the burn center where she worked have scars for the rest of their lives.The patient considered that there is a reasonable possibility that the events burns and permanent scarring were related to the device.She stated sometimes when you had a scar, it was sensitive to touch for years.She said if there wasn't a qa department to spot check this type of heat wrap, that there definitely should be.This was defective.She said she would retain the device but was unsure if she would be willing to send it back until she spoke with an attorney.They might suggest she keep it for a while.The last action taken in response to events for thermacare heatwrap was permanently withdrawn in (b)(6) 2020.The outcome of the events was unknown.According to the product quality complaint group on (b)(6) 2020: 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 wrap "kind of hot." the cause of the consumer reporting wrap being "kind of hot" is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot 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.Site sample status is not received.Follow-up (18mar2020): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the complaints of "burns second degree from alleged device issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue was assessed as non-serious.A causal relationship between the device and complaints cannot be ruled out.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.
|
| |
|
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 wrap "kind of hot." the cause of the consumer reporting wrap being "kind of hot¿ is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot 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.Site sample status is not received.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: batch cn9707 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: 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 wrap "kind of hot." the cause of the consumer reporting wrap being "kind of hot" is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the (name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status is not received.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] it burned her skin/she had 3 huge almost open wounds on her lower back/ kind of puffy and really painful and kind of hot like you get a burn and it was radiating heat/ burning sensation [burns second degree], it was almost like the product was defective because it only burned her right side on 3 areas [device issue], she had sciatica and sometimes it acted up and it really helped [intentional device use issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A 56-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number cn9707, expiration date aug2022, via an unspecified route of administration from (b)(6) 2020 to an unspecified date at an unknown dose for sciatica.Medical history and concomitant medications were none.The patient stated she purchased a 2 package box and used once and it helped really well.She stated a couple of days later, she had sciatica and sometimes it acted up and it really helped on (b)(6) 2020.She stated her sciatica acted up and sometimes it was hard for her to stand up and walk.She said heat improved muscle relaxation.She used to take medication for it and she did not like pills, so she stopped.The patient stated the first one worked great and she said it lasted for several days and she had a lot of pain, so she used the second one.She stated this time within just a couple of hours, it burned her skin and it had been 4 days and she had 3 huge almost open wounds on her lower back on (b)(6) 2020.She didn't know what to do.She stated it was still really painful.She took pictures.She didn't want this to happen to her or anyone else again.She didn't know if she should contact a lawyer or go through a doctor.The patient stated the first time she looked at the burn, it was raised and not a complete blister, clarifying it was kind of puffy and really painful and kind of hot like you got a burn and it was radiating heat.She had underwear on and pajama shorts and she put the wrap over both of those because she was 56 and it said if you are over 55 you need to wear something under it.She did not really notice it was burned until she took it off.It felt warm but it did not feel like it was burning her.She was really shocked.She thought, "what the heck, why is it so bad?" she touched it and it was very painful.The patient worked in administration in a hospital for 18 years and she worked with pfizer products with the hospital and subspecialty departments and there really had been good products.She stated her weight was between 175-180 lb.She did not have a primary care physician, because it was a teaching hospital that she worked at.She stated she could see how raw and red it was.She stated there were 3 burns on right side, clarifying it was almost like the product was defective because it only burned her right side on 3 areas.The left side was nothing.She could not determine the outcome and stated that when you touch it, it was still hot, but the burning sensation had improved a little bit.It was not completely gone.She had to be careful when she pulled underwear up.She could not have elastic near that.It irritated it.She stated she took aleve for that.The patient said she did not want to go to the doctor.She said it was a burn and she treated it as a burn.She worked in burn unit for 6 years.She knew how to treat it and was able to help herself.Unless she needed to for legal department, she would continue to try and take care of it herself.She stated she needed to get her glasses to read package.She did not indicate if she needed glasses prior to using product.She provided sep2023 at the end of lot number.The time stamp after that is 22:07.The product was a size small/medium and she did retain the product.She stated she would probably have scars for the rest of her life to her backside.She said without it healing, she wouldn't know how big the scars were, clarifying anytime you get a burn, they scar.She said it could have been a malfunction.She had seen many in the burn center where she worked have scars for the rest of their lives.The patient considered that there is a reasonable possibility that the events burns and permanent scarring were related to the device.She stated sometimes when you had a scar, it was sensitive to touch for years.She said if there wasn't a qa department to spot check this type of heat wrap, that there definitely should be.This was defective.She said she would retain the device but was unsure if she would be willing to send it back until she spoke with an attorney.They might suggest she keep it for a while.The last action taken in response to events for thermacare heatwrap was permanently withdrawn in mar2020.The outcome of the events was unknown.According to the product quality complaint group on 18mar2020: summary of investigation: batch cn9707 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: 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 wrap "kind of hot." the cause of the consumer reporting wrap being "kind of hot" is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the (name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status is not received.Reasonably suggest device malfunction was yes and severity of harm was s3 for subclass adverse event/serious/unknown and wrap/patch/pad too hot.Follow-up (b)(6) 2020: new information received from product quality complaint group includes investigation results.Follow-up (b)(6) 2020: new information received from a product complaint group included: severity of harm and malfunction assessment., comment: based on the information provided, the complaints of "burns second degree from alleged device issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue was assessed as non-serious.A causal relationship between the device and complaints cannot be ruled out.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.
|
| |
|
Search Alerts/Recalls
|
|
|
