|
|
| Lot Number W91244 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Sleep Dysfunction (2517); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)
|
| Event Date 01/12/2019 |
|
Event Type
Injury
|
|
Event Description
|
|
Event verbatim [preferred term] burnt her/ her mom now has pus coming out of the blisters/ because of the pain [burns second degree], blood pressure went up over 190 [blood pressure increased], she was not able to sleep [insomnia].Case narrative: this is a spontaneous report from a contactable consumer reporting for her mother.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number w91244, expiration date jul2021, (b)(4), via an unspecified route of administration from an unspecified date to an unspecified date since her back was hurting.The patient medical history and concomitant medications were not reported.Caller stated her mom used thermacare heatwraps back pain therapy advanced l-xl and it burnt her on (b)(6) 2019.Her mom now has pus coming out of the blisters.She stated her mom's blood pressure went up over 190 and she was not able to sleep, because of the pain.Caller stated this was a potential legal matter.She did have a picture if requested.Agent stated she advised the caller that the product packaging does recommend people over 55 years old should wear the product over a layer of clothing.Her mom said she had a thin t-shirt under the heatwrap.It was a thin tank top.Caller stated the area was on her mom's lower back, near the bottom.It was a disaster.Her mom put the product on at about 7:00 pm or 8:00 pm.She confirmed her mom was awake the whole time she wore the product.Her mom took it off less than an hour after putting it on.She came home and felt it on her mom and it was so hot, it was burning.Caller clarified that by burning she means it was very hot.When her mom took it off, it was a disaster, and she could see the spots.She was taking her mom to the doctor today, (b)(6) 2019 for treatment.Her mom has always used these products, it was not like it is the first time she ever used it.A sample of the product was available to be returned if requested.Investigation assessment: no.The action taken for the product was unknown.The outcome of the event "burnt her/ her mom now has pus coming out of the blisters/ because of the pain" was resolved with sequel on (b)(6) 2019.The outcome of other 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 "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "blood pressure increase" is serious."insomnia" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "blood pressure increase" is serious."insomnia" is non-serious.The events are medically assessed as associated with the use of the device.
|
| |
|
Event Description
|
|
Burnt her/ her mom now has pus coming out of the blisters/ because of the pain [burns second degree] , blood pressure went up over 190 [blood pressure increased] , she was not able to sleep [insomnia].Case narrative:this is a spontaneous report from a contactable consumer reporting for her mother.A 77-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: w91244, expiration date jul2021, upc number: (b)(4), via an unspecified route of administration from an unspecified date to an unspecified date since her back was hurting.The patient medical history and concomitant medications were not reported.Caller stated her mom used thermacare heatwraps back pain therapy advanced l-xl and it burnt her on (b)(6) 2019.Her mom now has pus coming out of the blisters.She stated her mom's blood pressure went up over 190 and she was not able to sleep, because of the pain.Caller stated this was a potential legal matter.She did have a picture if requested.Agent stated she advised the caller that the product packaging does recommend people over 55 years old should wear the product over a layer of clothing.Her mom said she had a thin t-shirt under the heatwrap.It was a thin tank top.Caller stated the area was on her mom's lower back, near the bottom.It was a disaster.Her mom put the product on at about 7:00 pm or 8:00 pm.She confirmed her mom was awake the whole time she wore the product.Her mom took it off less than an hour after putting it on.She came home and felt it on her mom and it was so hot, it was burning.Caller clarified that by burning she means it was very hot.When her mom took it off, it was a disaster, and she could see the spots.She was taking her mom to the doctor today (on (b)(6) 2019) for treatment.Her mom has always used these products, it was not like it is the first time she ever used it.A sample of the product was available to be returned if requested.The product quality group provided their investigation summary as follows: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap was "it was so hot".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support 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.The action taken for the product was unknown.The outcome of the event "burnt her/ her mom now has pus coming out of the blisters/ because of the pain" was resolved with sequel on (b)(6) 2019.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (18jan2019).New information received from the product quality complaints group includes: investigation summary.Company clinical evaluation comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "blood pressure increase" is serious."insomnia" is non-serious.The events are medically assessed as 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., comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "blood pressure increase" is serious."insomnia" is non-serious.The events are medically assessed as 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.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap was "it was so hot".The cause of the consumer stating the wrap was too hot is inconclusive since review of records does not provide evidence to support 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.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burnt her/ her mom now has pus coming out of the blisters/ because of the pain [burns second degree] , it was so hot [device issue] , blood pressure went up over 190 [blood pressure increased] , she was not able to sleep [insomnia] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for her mother.A 77-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number w91244, expiration date jul2021, upc number: 0573301003, via an unspecified route of administration from an unspecified date to an unspecified date since her back was hurting.The patient medical history and concomitant medications were not reported.Caller stated her mom used thermacare heatwraps back pain therapy advanced l-xl and it burnt her on 12jan2019.Her mom now has pus coming out of the blisters.She stated her mom's blood pressure went up over 190 and she was not able to sleep, because of the pain.Caller stated this was a potential legal matter.She did have a picture if requested.Agent stated she advised the caller that the product packaging does recommend people over 55 years old should wear the product over a layer of clothing.Her mom said she had a thin t-shirt under the heatwrap.It was a thin tank top.Caller stated the area was on her mom's lower back, near the bottom.It was a disaster.Her mom put the product on at about 7:00 pm or 8:00 pm.She confirmed her mom was awake the whole time she wore the product.Her mom took it off less than an hour after putting it on.She came home and felt it on her mom and it was so hot, it was burning.Caller clarified that by burning she means it was very hot.When her mom took it off, it was a disaster, and she could see the spots.She was taking her mom to the doctor today (14jan2019) for treatment.Her mom has always used these products, it was not like it is the first time she ever used it.The action taken for the product was unknown.The outcomes of the events "burnt her/ her mom now has pus coming out of the blisters/ because of the pain" and "it was so hot" were resolved with sequel on (b)(6) 2019.The outcome of other events was unknown.A sample of the product was available to be returned if requested.The product quality group provided their investigation summary as follows: the visual inspection of retain samples included one carton, and the two pouched wraps inside.Inspection shows no obvious defects to carton, or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 17jan2019 for a related complaint.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation 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.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 defects recorded for the batch.One variable defect was recorded for the batch for the hook to fold; adjustments were made to the hook to edge distance.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.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 the wrap caused "it was so hot" and "pus coming out of the blisters and burning" the cause of "it was so hot, the blisters and burn" are inconclusive since review of records does not provide evidence to support 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.Follow-up (18jan2019).New information received from the product quality complaints group includes: investigation summary.Follow-up (15mar2019): new information received from the product quality complaints group includes: investigation summary and additional event "it was so hot" added.Follow-up (19apr2019): follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: product problem was ticked.Company clinical evaluation comment based on the information provided, the events of "burn blisters" and "it was so hot" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "blood pressure increase" is serious.Event "insomnia" is non-serious.The events are medically assessed as 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., comment: based on the information provided, the events of "burn blisters" and "it was so hot" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "blood pressure increase" is serious.Event "insomnia" is non-serious.The events are medically assessed as 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.
|
| |
|
Manufacturer Narrative
|
|
The visual inspection of retain samples included one carton, and the two pouched wraps inside.Inspection shows no obvious defects to carton, or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 17jan2019 for a related complaint.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation 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.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 defects recorded for the batch.One variable defect was recorded for the batch for the hook to fold; adjustments were made to the hook to edge distance.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.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 the wrap caused "it was so hot" and ¿ pus coming out of the blisters and burning.¿ the cause of "it was so hot" and the blisters and burn are inconclusive since review of records does not provide evidence to support 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 sampl.
|
| |
|
Manufacturer Narrative
|
|
The visual inspection of retain samples included one carton, and the two pouched wraps inside.Inspection shows no obvious defects to carton, or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 17jan2019 for a related complaint.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation 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.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 defects recorded for the batch.One variable defect was recorded for the batch for the hook to fold; adjustments were made to the hook to edge distance.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.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 the wrap caused "it was so hot" and ¿ pus coming out of the blisters and burning.¿ the cause of "it was so hot" and the blisters and burn are inconclusive since review of records does not provide evidence to support 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 sampl.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burnt her/ her mom now has pus coming out of the blisters/ because of the pain [burns second degree] , it was so hot [device issue] , blood pressure went up over 190 [blood pressure increased] , she was not able to sleep [insomnia] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for her mother.A 77-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number w91244, expiration date jul2021, upc number: 0573301003, via an unspecified route of administration from an unspecified date to an unspecified date since her back was hurting.The patient medical history and concomitant medications were not reported.Caller stated her mom used thermacare heatwraps back pain therapy advanced l-xl and it burnt her on (b)(6) 2019.Her mom now has pus coming out of the blisters.She stated her mom's blood pressure went up over 190 and she was not able to sleep, because of the pain.Caller stated this was a potential legal matter.She did have a picture if requested.Agent stated she advised the caller that the product packaging does recommend people over 55 years old should wear the product over a layer of clothing.Her mom said she had a thin t-shirt under the heatwrap.It was a thin tank top.Caller stated the area was on her mom's lower back, near the bottom.It was a disaster.Her mom put the product on at about 7:00 pm or 8:00 pm.She confirmed her mom was awake the whole time she wore the product.Her mom took it off less than an hour after putting it on.She came home and felt it on her mom and it was so hot, it was burning.Caller clarified that by burning she means it was very hot.When her mom took it off, it was a disaster, and she could see the spots.She was taking her mom to the doctor today ((b)(6) 2019) for treatment.Her mom has always used these products, it was not like it is the first time she ever used it.The action taken for the product was unknown.The outcomes of the events "burnt her/ her mom now has pus coming out of the blisters/ because of the pain" and "it was so hot" were resolved with sequel on (b)(6) 2019.The outcome of other events was unknown.A sample of the product was available to be returned if requested.The product quality group provided their investigation summary as follows: the visual inspection of retain samples included one carton, and the two pouched wraps inside.Inspection shows no obvious defects to carton, or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 17jan2019 for a related complaint.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation 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.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 defects recorded for the batch.One variable defect was recorded for the batch for the hook to fold; adjustments were made to the hook to edge distance.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.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 the wrap caused "it was so hot" and "pus coming out of the blisters and burning" the cause of "it was so hot, the blisters and burn" are inconclusive since review of records does not provide evidence to support 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.Follow-up (18jan2019).New information received from the product quality complaints group includes: investigation summary.Follow-up (15mar2019): new information received from the product quality complaints group includes: investigation summary and additional event "it was so hot" added.Company clinical evaluation comment: based on the information provided, the events of "burn blisters" and "it was so hot" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "blood pressure increase" is serious.Event "insomnia" is non-serious.The events are medically assessed as 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., comment: based on the information provided, the events of "burn blisters" and "it was so hot" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "blood pressure increase" is serious.Event "insomnia" is non-serious.The events are medically assessed as 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.
|
| |
|
Search Alerts/Recalls
|
|
|
