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| Lot Number DK2617 |
| Device Problems
Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Therapeutic or Diagnostic Output Failure (3023); Excessive Heating (4030)
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| Patient Problems
Swelling (2091); Urticaria (2278); Burn, Thermal (2530); Ambulation Difficulties (2544)
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| Event Date 10/22/2020 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term].Got burned by the last one, and this one/they were burning skin [thermal burn], she has a red welt on her skin [urticaria], it was too, too hot/the muscles were swelling from having more heat that was too intense [device issue], had a hard time walking, like the muscles were swelling from having more heat that was too intense [gait disturbance], had a hard time walking, like the muscles were swelling from having more heat that was too intense [muscle swelling], it wasn't helping her back pain, it was accelerating pain from her lower lumbar [device ineffective], making more pain for her back/it was accelerating pain from her lower lumbar [back pain], put it on her back by her lumbar for back pain [device use issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2617, expiration date feb2023, upc number: (b)(4), from an unspecified date at one heat wrap applied to lower back/lumbar as needed for back pain.Medical history included ongoing blood pressure high and ongoing kidney disease, and patient stated it was a year and a half ago (in 2019) those were diagnosed.Concomitant medication included taking unspecified pills for high blood pressure.For her kidney disease she drank a lot of water.The patient was reported for thermacare neck pain therapy heat wraps 16 hours.She reported that this was the second box she bought, and she got burned by the last one, and this one.She used it for close to four hours, not even close to 16 hours and wanted to let the company know.She put it on her back by her lumbar.The patient reported that they were burning skin.She stated she was looking for the number before in (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.She stated she thought that if she threw that box out and got another box which she used one of them yesterday (on (b)(6) 2020) and it hurt real bad, that she would try another today (on (b)(6) 2020), which she did around 11:00 and that one started.She clarified she only used today ((b)(6) 2020)'s heat wrap for 3 hours.She stated it was fine for a couple hours then like when you are driving a car and put your foot down on the pedal and it started accelerating.She stated she put it on about eleven and at two o'clock on (b)(6) 2020 she couldn't stand it anymore, it wasn't helping her back pain, it was accelerating pain from her lower lumbar.She stated it was too, too hot.It was not near her kidneys, it was near her lower lumbar.The patient clarified that the pain was not near her kidneys, and that was not where she applied the heat wrap, she would never put one up on that area.The patient clarified that when she said her skin was burned that to the left side of it she had a red welt on her skin.She had a hard time walking, like the muscles were swelling from having more heat that was too intense.She stated she could barely walk with this thing on, and she was out and came home immediately took it off since it was only making more pain for her back, and had to lay down for a while.The patient didn't do anything to treat the skin after taking the heat wrap off.She stated she has got medical issues also, but for the she needed relief so she used these (referring to thermacare).The patient stated she used to use these on her (b)(6) year old mom, the ones for 8 hours, those were great, and she would have used the 8 hours, but they didn't have those now, only 16 hours since.She bought two boxes of the 16 hours, and it has been damaging to the skin.She was thinking of her mom, and that it was a good thing she wasn't using these when she was using on her back then.Those were the 8 hour ones; these new 16 hours ones were not right.She stated if anybody in a nursing home put one of these on an elderly person, she would hate to think of that happening.The patient hadn't thrown out the box yet.She threw out the first box she had, and bought a new box and gave a box to her brother who she was going to tell him don't take it.She needed her glasses to read the upc.After the lot it says 03/09 like a date when it was made or something expires.She says that there were three wraps in a box.She threw out the one she had on, and threw out the other one she had, she had only got one left.The patient didn't have the other box to provide upc/lot/exp from it, she only had one heat wrap left, she threw the other two away, one was outside in the garage.She reported that the heat wraps were sealed and intact, they were fine.The sample of the device was available to be returned.The action taken in response to the events was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available.
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Event Description
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Got burned by the last one, and this one/they were burning skin [thermal burn], she has a red welt on her skin [urticaria], it was too, too hot/the muscles were swelling from having more heat that was too intense [device issue], had a hard time walking, like the muscles were swelling from having more heat that was too intense [gait disturbance], had a hard time walking, like the muscles were swelling from having more heat that was too intense [muscle swelling], it wasn't helping her back pain, it was accelerating pain from her lower lumbar [device ineffective], put it on her back by her lumbar for back pain [device use issue], making more pain for her back/it was accelerating pain from her lower lumbar [back pain], narrative: this is a spontaneous report from a contactable consumer (patient).A 71-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2617, expiration date feb2023, upc/udi number (b)(4), from an unspecified date at one heat wrap applied to lower back/lumbar as needed for back pain.Medical history included ongoing blood pressure high and ongoing kidney disease, and patient stated it was a year and a half before (in 2019) those were diagnosed.Concomitant medication included taking unspecified pills for high blood pressure.For her kidney disease she drank a lot of water.The patient was reported for thermacare neck pain therapy heat wraps 16 hours.She reported that this was the second box she bought, and she got burned by the last one, and this one.She used it for close to four hours, not even close to 16 hours and wanted to let the company know.She put it on her back by her lumbar.The patient reported that they were burning skin.She stated she was looking for the number before in (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.She stated she thought that if she threw that box out and got another box which she used one of them yesterday (on (b)(6) 2020) and it hurt real bad, that she would try another today (on (b)(6) 2020), which she did around 11:00 and that one started.She clarified she only used today(b)(6) 2020's heat wrap for 3 hours.She stated it was fine for a couple hours then like when you are driving a car and put your foot down on the pedal and it started accelerating.She stated she put it on about eleven and at two o'clock on (b)(6) 2020 she couldn't stand it anymore, it wasn't helping her back pain, it was accelerating pain from her lower lumbar.She stated it was too, too hot.It was not near her kidneys, it was near her lower lumbar.The patient clarified that the pain was not near her kidneys, and that was not where she applied the heat wrap, she would never put one up on that area.The patient clarified that when she said her skin was burned that to the left side of it she had a red welt on her skin.She had a hard time walking, like the muscles were swelling from having more heat that was too intense.She stated she could barely walk with this thing on, and she was out and came home immediately took it off since it was only making more pain for her back, and had to lay down for a while.The patient didn't do anything to treat the skin after taking the heat wrap off.She stated she has got medical issues also, but for the she needed relief so she used these (referring to thermacare).The patient stated she used to use these on her 88 year old mom, the ones for 8 hours, those were great, and she would have used the 8 hours, but they didn't have those now, only 16 hours since.She bought two boxes of the 16 hours, and it has been damaging to the skin.She was thinking of her mom, and that it was a good thing she wasn't using these when she was using on her back then.Those were the 8 hour ones; these new 16 hours ones were not right.She stated if anybody in a nursing home put one of these on an elderly person, she would hate to think of that happening.The patient hadn't thrown out the box yet.She threw out the first box she had, and bought a new box and gave a box to her brother who she was going to tell him don't take it.She needed her glasses to read the upc.After the lot it says 03/09 like a date when it was made or something expires.She says that there were three wraps in a box.She threw out the one she had on, and threw out the other one she had, she had only got one left.The patient didn't have the other box to provide upc/lot/exp from it, the patient also reported "too hot and damaging to skin" for unknown lot.She only had one heat wrap left, she threw the other two away, one was outside in the garage.She reported that the heat wraps were sealed and intact, they were fine.The sample of the device was available to be returned.The action taken in response to the events was unknown.The outcome of the events was unknown.On 03nov2020, according to the product quality complaint group: complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.On 13nov2020, the product quality complaint group provided the following investigation results.Complaint sub-class: wrap/patch/pad too hot.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related was no; final confirmation status was not confirmed.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 "they are burning skin." the cause of the consumer stating "they are burning skin" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Site sample status was not received.On 15dec2020, the product quality complaint group provided the following investigation results for unknown lot.Complaint sub-class: wrap/patch/pad too hot.This investigation was conducted for an unknown lot number nsw 8hr product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass wrap/patch/pad too hot.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Refer to the 36-month trending chart attachment nsw 8hr too hot (b)(6) 2020.Process related: no.Final confirmation status: not confirmed.Site sample status: not received.Follow-up (03nov2020): new information received from the product quality complaint group included investigational results.Follow-up (13nov2020): new information received from the product quality complaint group included: additional investigation results.Follow-up (23nov2020): follow-up attempts completed.No further information expected.Follow-up (11dec2020): new information received from the product quality complaint group includes investigational results for complaint sub-class heat cells damaged/leaking revised from lot number dk2617 to unknown lot number and thus the investigational results removed.Trend information for complaint sub-class wrap/patch/pad too hot added.Follow-up attempts are completed.No further information is expected.Follow-up (15dec2020): new information received from product quality complaint group includes investigational results for complaint sub-class wrap/patch/pad too hot for unknown lot.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.Complaint sub-class: wrap/patch/pad too hot.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related was no; final confirmation status was not confirmed.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 "they are burning skin." the cause of the consumer stating "they are burning skin" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Site sample status was not received.Complaint sub-class: wrap/patch/pad too hot for unknown lot.This investigation was conducted for an unknown lot number nsw 8hr product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass wrap/patch/pad too hot.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Refer to the 36-month trending chart attachment nsw 8hr too hot (b)(6) 2020.Process related: no.Final confirmation status: not confirmed.Site sample status: not received.
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Event Description
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Event verbatim [preferred term]: got burned by the last one, and this one/they were burning skin [thermal burn], she has a red welt on her skin [urticaria], it was too, too hot/the muscles were swelling from having more heat that was too intense [device issue], had a hard time walking, like the muscles were swelling from having more heat that was too intense [gait disturbance], had a hard time walking, like the muscles were swelling from having more heat that was too intense [muscle swelling], it wasn't helping her back pain, it was accelerating pain from her lower lumbar [device ineffective], making more pain for her back/it was accelerating pain from her lower lumbar [back pain], put it on her back by her lumbar for back pain [device use issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A 71-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2617, expiration date feb2023, upc/udi number (b)(4), from an unspecified date at one heat wrap applied to lower back/lumbar as needed for back pain.Medical history included ongoing blood pressure high and ongoing kidney disease, and patient stated it was a year and a half before (in 2019) those were diagnosed.Concomitant medication included taking unspecified pills for high blood pressure.For her kidney disease she drank a lot of water.The patient was reported for thermacare neck pain therapy heat wraps 16 hours.She reported that this was the second box she bought, and she got burned by the last one, and this one.She used it for close to four hours, not even close to 16 hours and wanted to let the company know.She put it on her back by her lumbar.The patient reported that they were burning skin.She stated she was looking for the number before in (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.She stated she thought that if she threw that box out and got another box which she used one of them yesterday (on (b)(6) 2020) and it hurt real bad, that she would try another today (on (b)(6) 2020), which she did around 11:00 and that one started.She clarified she only used today( (b)(6) 2020)'s heat wrap for 3 hours.She stated it was fine for a couple hours then like when you are driving a car and put your foot down on the pedal and it started accelerating.She stated she put it on about eleven and at two o'clock on (b)(6) 2020 she couldn't stand it anymore, it wasn't helping her back pain, it was accelerating pain from her lower lumbar.She stated it was too, too hot.It was not near her kidneys, it was near her lower lumbar.The patient clarified that the pain was not near her kidneys, and that was not where she applied the heat wrap, she would never put one up on that area.The patient clarified that when she said her skin was burned that to the left side of it she had a red welt on her skin.She had a hard time walking, like the muscles were swelling from having more heat that was too intense.She stated she could barely walk with this thing on, and she was out and came home immediately took it off since it was only making more pain for her back, and had to lay down for a while.The patient didn't do anything to treat the skin after taking the heat wrap off.She stated she has got medical issues also, but for the she needed relief so she used these (referring to thermacare).The patient stated she used to use these on her 88 year old mom, the ones for 8 hours, those were great, and she would have used the 8 hours, but they didn't have those now, only 16 hours since.She bought two boxes of the 16 hours, and it has been damaging to the skin.She was thinking of her mom, and that it was a good thing she wasn't using these when she was using on her back then.Those were the 8 hour ones; these new 16 hours ones were not right.She stated if anybody in a nursing home put one of these on an elderly person, she would hate to think of that happening.The patient hadn't thrown out the box yet.She threw out the first box she had, and bought a new box and gave a box to her brother who she was going to tell him don't take it.She needed her glasses to read the upc.After the lot it says 03/09 like a date when it was made or something expires.She says that there were three wraps in a box.She threw out the one she had on, and threw out the other one she had, she had only got one left.The patient didn't have the other box to provide upc/lot/exp from it, she only had one heat wrap left, she threw the other two away, one was outside in the garage.She reported that the heat wraps were sealed and intact, they were fine.The sample of the device was available to be returned.The action taken in response to the events was unknown.The outcome of the events was unknown.On 03nov2020, according to the product quality complaint group: complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.On 13nov2020, the product quality complaint group provided the following investigation results.Complaint sub-class: wrap/patch/pad too hot.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related was no; final confirmation status was not confirmed.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 "they are burning skin.".The cause of the consumer stating "they are burning skin" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Site sample status was not received.Follow-up ((b)(6) 2020): new information received from the product quality complaint group included investigational results.Follow-up (03nov2020): new information received from the product quality complaint group included: additional investigation results.Follow-up (13nov2020): follow-up attempts completed.No further information expected.Follow-up ((b)(6) 2020): new information received from the product quality complaint group includes investigational results for complaint sub-class heat cells damaged/leaking revised from lot number dk2617 to unknown lot number and thus the investigational results removed.Trend information for complaint sub-class wrap/patch/pad too hot added.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.Complaint sub-class: wrap/patch/pad too hot.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related was no; final confirmation status was not confirmed.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 "they are burning skin." the cause of the consumer stating "they are burning skin" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Site sample status was not received.
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Event Description
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Got burned by the last one, and this one / they were burning skin [thermal burn], she has a red welt on her skin [urticaria], it was too, too hot / the muscles were swelling from having more heat that was too intense [device issue], had a hard time walking, like the muscles were swelling from having more heat that was too intense [gait disturbance], had a hard time walking, like the muscles were swelling from having more heat that was too intense [muscle swelling], it wasn't helping her back pain, it was accelerating pain from her lower lumbar [device ineffective], making more pain for her back / it was accelerating pain from her lower lumbar [back pain], put it on her back by her lumbar for back pain [device use issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A 71-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number: dk2617, expiration date: feb2023, upc number: 305733015025, from an unspecified date at one heat wrap applied to lower back / lumbar as needed for back pain.Medical history included ongoing blood pressure high and ongoing kidney disease, and patient stated it was a year and a half before (in 2019) those were diagnosed.Concomitant medication included taking unspecified pills for high blood pressure.For her kidney disease she drank a lot of water.The patient was reported for thermacare neck pain therapy heat wraps 16 hours.She reported that this was the second box she bought, and she got burned by the last one, and this one.She used it for close to four hours, not even close to 16 hours and wanted to let the company know.She put it on her back by her lumbar.The patient reported that they were burning skin.She stated she was looking for the number before on (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.She stated she thought that if she threw that box out and got another box which she used one of them yesterday (on (b)(6) 2020) and it hurt real bad, that she would try another today (on (b)(6) 2020), which she did around 11:00 and that one started.She clarified she only used today(on (b)(6) 2020)'s heat wrap for 3 hours.She stated it was fine for a couple hours then like when you are driving a car and put your foot down on the pedal and it started accelerating.She stated she put it on about eleven and at two o'clock on (b)(6) 2020 she couldn't stand it anymore, it wasn't helping her back pain, it was accelerating pain from her lower lumbar.She stated it was too, too hot.It was not near her kidneys, it was near her lower lumbar.The patient clarified that the pain was not near her kidneys, and that was not where she applied the heat wrap, she would never put one up on that area.The patient clarified that when she said her skin was burned that to the left side of it she had a red welt on her skin.She had a hard time walking, like the muscles were swelling from having more heat that was too intense.She stated she could barely walk with this thing on, and she was out and came home immediately took it off since it was only making more pain for her back, and had to lay down for a while.The patient didn't do anything to treat the skin after taking the heat wrap off.She stated she has got medical issues also, but for the she needed relief so she used these (referring to thermacare).The patient stated she used to use these on her 88 year old mom, the ones for 8 hours, those were great, and she would have used the 8 hours, but they didn't have those now, only 16 hours since.She bought two boxes of the 16 hours, and it has been damaging to the skin.She was thinking of her mom, and that it was a good thing she wasn't using these when she was using on her back then.Those were the 8 hour ones; these new 16 hours ones were not right.She stated if anybody in a nursing home put one of these on an elderly person, she would hate to think of that happening.The patient hadn't thrown out the box yet.She threw out the first box she had, and bought a new box and gave a box to her brother who she was going to tell him don't take it.She needed her glasses to read the upc.After the lot it says 03/2009 like a date when it was made or something expires.She says that there were three wraps in a box.She threw out the one she had on, and threw out the other one she had, she had only got one left.The patient didn't have the other box to provide upc / lot / exp from it, she only had one heat wrap left, she threw the other two away, one was outside in the garage.She reported that the heat wraps were sealed and intact, they were fine.The sample of the device was available to be returned.The action taken in response to the events was unknown.The outcome of the events was unknown.On 03nov2020, according to the product quality complaint group: description of compliant: "got burned".Complaint sub-class: adverse event / serious / unknown.Summary of investigation: batch#: dk2617; product count: 3 count date of manufacture: 06mar2020 to 18mar2020; expiry date: feb2023; quantity released: 382,680 cartons; batch: dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.On 13nov2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare neck, shoulder & wrist.Device lot number: dk2617.Expiration date: feb2023.Description of compliant: "she thought these must be leaking too".Complaint sub-class: heat cells damaged / leaking.Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.Summary of investigation: batch: dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause / capa: process related?: no; final confirmation status: not confirmed; vendor related?: no; root cause category: non-assignable.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.On 13nov2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare neck, shoulder & wrist.Device lot number: dk2617.Expiration date: feb2023.Description of compliant: "it was too, too hot".Complaint sub-class: complaint sub-class: wrap / patch / pad too hot.Reasonably suggest device malfunction: yes.Severity of harm: n/a.Site sample status: not received.Summary of investigation: batch: dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause / capa: process related?: no; final confirmation status: not confirmed; vendor related?: no; root cause category: non-assignable.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 "they are burning skin." the cause of the consumer stating "they are burning skin" 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.Follow-up (03nov2020): new information received from the product quality complaint group included investigational results.Follow-up (13nov2020): new information received from the product quality complaint group included: additional investigation results.
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Manufacturer Narrative
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On 03nov2020, according to the product quality complaint group: description of compliant: "got burned".Complaint sub-class: adverse event / serious / unknown.Summary of investigation: batch#: dk2617; product count: 3 count date of manufacture: 06mar2020 to 18mar2020; expiry date: feb2023; quantity released: 382,680 cartons; batch: dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event / serious / unknown received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.On 13nov2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare neck, shoulder & wrist.Device lot number: dk2617.Expiration date: feb2023.Description of compliant: "she thought these must be leaking too".Complaint sub-class: heat cells damaged / leaking.Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.Summary of investigation: batch: dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause / capa: process related?: no; final confirmation status: not confirmed; vendor related?: no; root cause category: non-assignable.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.On 13nov2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare neck, shoulder & wrist.Device lot number: dk2617.Expiration date: feb2023.Description of compliant: "it was too, too hot".Complaint sub-class: complaint sub-class: wrap / patch / pad too hot.Reasonably suggest device malfunction: yes.Severity of harm: n/a.Site sample status: not received.Summary of investigation: batch: dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related?: no; final confirmation status: not confirmed; vendor related?: no; root cause category: non-assignable.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 "they are burning skin." the cause of the consumer stating "they are burning skin" 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.
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Manufacturer Narrative
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Summary of investigation: batch #: dk2617; product count: 3 count date of manufacture: 06mar2020 to 18mar2020; expiry date: feb2023; quantity released: (b)(4) cartons; batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.
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Event Description
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Event [preferred term] got burned by the last one, and this one/they were burning skin [thermal burn], she has a red welt on her skin [urticaria], it was too, too hot/the muscles were swelling from having more heat that was too intense [device issue], had a hard time walking, like the muscles were swelling from having more heat that was too intense [gait disturbance], had a hard time walking, like the muscles were swelling from having more heat that was too intense [muscle swelling], it wasn't helping her back pain, it was accelerating pain from her lower lumbar [device ineffective], making more pain for her back/it was accelerating pain from her lower lumbar [back pain], put it on her back by her lumbar for back pain [device use issue], narrative: this is a spontaneous report from a contactable consumer (patient).A 71-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2617, expiration date feb2023, upc number: 305733015025, from an unspecified date at one heat wrap applied to lower back/lumbar as needed for back pain.Medical history included ongoing blood pressure high and ongoing kidney disease, and patient stated it was a year and a half ago (in 2019) those were diagnosed.Concomitant medication included taking unspecified pills for high blood pressure.For her kidney disease she drank a lot of water.The patient was reported for thermacare neck pain therapy heat wraps 16 hours.She reported that this was the second box she bought, and she got burned by the last one, and this one.She used it for close to four hours, not even close to 16 hours and wanted to let the company know.She put it on her back by her lumbar.The patient reported that they were burning skin.She stated she was looking for the number before in (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.She stated she thought that if she threw that box out and got another box which she used one of them yesterday (on (b)(6) 2020) and it hurt real bad, that she would try another today (on (b)(6) 2020), which she did around 11:00 and that one started.She clarified she only used today((b)(6) 2020)'s heat wrap for 3 hours.She stated it was fine for a couple hours then like when you are driving a car and put your foot down on the pedal and it started accelerating.She stated she put it on about eleven and at two o'clock on (b)(6) 2020 she couldn't stand it anymore, it wasn't helping her back pain, it was accelerating pain from her lower lumbar.She stated it was too, too hot.It was not near her kidneys; it was near her lower lumbar.The patient clarified that the pain was not near her kidneys, and that was not where she applied the heat wrap, she would never put one up on that area.The patient clarified that when she said her skin was burned that to the left side of it, she had a red welt on her skin.She had a hard time walking, like the muscles were swelling from having more heat that was too intense.She stated she could barely walk with this thing on, and she was out and came home immediately took it off since it was only making more pain for her back and had to lay down for a while.The patient didn't do anything to treat the skin after taking the heat wrap off.She stated she has got medical issues also, but for the she needed relief so she used these (referring to thermacare).The patient stated she used to use these on her 88-year-old mom, the ones for 8 hours, those were great, and she would have used the 8 hours, but they didn't have those now, only 16 hours since.She bought two boxes of the 16 hours, and it has been damaging to the skin.She was thinking of her mom, and that it was a good thing she wasn't using these when she was using on her back then.Those were the 8 hour ones; these new 16 hours ones were not right.She stated if anybody in a nursing home put one of these on an elderly person, she would hate to think of that happening.The patient hadn't thrown out the box yet.She threw out the first box she had and bought a new box and gave a box to her brother who she was going to tell him don't take it.She needed her glasses to read the upc.After the lot it says 03/09 like a date when it was made or something expires.She says that there were three wraps in a box.She threw out the one she had on, and threw out the other one she had, she had only got one left.The patient didn't have the other box to provide upc/lot/exp from it, she only had one heat wrap left, she threw the other two away, one was outside in the garage.She reported that the heat wraps were sealed and intact, they were fine.The sample of the device was available to be returned.The action taken in response to the events was unknown.The outcome of the events was unknown.According to the product quality complaint group: summary of investigation: batch #: dk2617; product count: 3 count date of manufacture: 06mar2020 to 18mar2020; expiry date: feb2023; quantity released: (b)(4) cartons; batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.Follow-up (03nov2020): new information received from the product quality complaint group included investigational results.
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Event Description
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Event verbatim [preferred term]: got burned by the last one, and this one/they were burning skin [thermal burn], she has a red welt on her skin [urticaria], it was too, too hot/the muscles were swelling from having more heat that was too intense [device issue], had a hard time walking, like the muscles were swelling from having more heat that was too intense [gait disturbance], had a hard time walking, like the muscles were swelling from having more heat that was too intense [muscle swelling], it wasn't helping her back pain, it was accelerating pain from her lower lumbar [device ineffective], put it on her back by her lumbar for back pain [device use issue], making more pain for her back/it was accelerating pain from her lower lumbar [back pain], narrative: this is a spontaneous report from a contactable consumer (patient).A 71-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2617, expiration date feb2023, upc/udi number (b)(4), from an unspecified date at one heat wrap applied to lower back/lumbar as needed for back pain.Medical history included ongoing blood pressure high and ongoing kidney disease, and patient stated it was a year and a half before (in 2019) those were diagnosed.Concomitant medication included taking unspecified pills for high blood pressure.For her kidney disease she drank a lot of water.The patient was reported for thermacare neck pain therapy heat wraps 16 hours.She reported that this was the second box she bought, and she got burned by the last one, and this one.She used it for close to four hours, not even close to 16 hours and wanted to let the company know.She put it on her back by her lumbar.The patient reported that they were burning skin.She stated she was looking for the number before in (b)(6) 2019 for the same product but she didn't know if those were the neck ones because they said they were leaking so she thought these must be leaking too.She stated she thought that if she threw that box out and got another box which she used one of them yesterday (on (b)(6) 2020) and it hurt real bad, that she would try another today (on (b)(6) 2020), which she did around 11:00 and that one started.She clarified she only used today ((b)(6) 2020) heat wrap for 3 hours.She stated it was fine for a couple hours then like when you are driving a car and put your foot down on the pedal and it started accelerating.She stated she put it on about eleven and at two o'clock on (b)(6) 2020 she couldn't stand it anymore, it wasn't helping her back pain, it was accelerating pain from her lower lumbar.She stated it was too, too hot.It was not near her kidneys, it was near her lower lumbar.The patient clarified that the pain was not near her kidneys, and that was not where she applied the heat wrap, she would never put one up on that area.The patient clarified that when she said her skin was burned that to the left side of it she had a red welt on her skin.She had a hard time walking, like the muscles were swelling from having more heat that was too intense.She stated she could barely walk with this thing on, and she was out and came home immediately took it off since it was only making more pain for her back, and had to lay down for a while.The patient didn't do anything to treat the skin after taking the heat wrap off.She stated she has got medical issues also, but for the she needed relief so she used these (referring to thermacare).The patient stated she used to use these on her 88 year old mom, the ones for 8 hours, those were great, and she would have used the 8 hours, but they didn't have those now, only 16 hours since.She bought two boxes of the 16 hours, and it has been damaging to the skin.She was thinking of her mom, and that it was a good thing she wasn't using these when she was using on her back then.Those were the 8 hour ones; these new 16 hours ones were not right.She stated if anybody in a nursing home put one of these on an elderly person, she would hate to think of that happening.The patient hadn't thrown out the box yet.She threw out the first box she had, and bought a new box and gave a box to her brother who she was going to tell him don't take it.She needed her glasses to read the upc.After the lot it says 03/09 like a date when it was made or something expires.She says that there were three wraps in a box.She threw out the one she had on, and threw out the other one she had, she had only got one left.The patient didn't have the other box to provide upc/lot/exp from it, the patient also reported "too hot and damaging to skin" for unknown lot.She only had one heat wrap left, she threw the other two away, one was outside in the garage.She reported that the heat wraps were sealed and intact, they were fine.The sample of the device was available to be returned.The action taken in response to the events was unknown.The outcome of the events was unknown.On 03nov2020, according to the product quality complaint group: complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.On 13nov2020, the product quality complaint group provided the following investigation results.Complaint sub-class: wrap/patch/pad too hot.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related was no; final confirmation status was not confirmed.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 "they are burning skin." the cause of the consumer stating "they are burning skin" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Site sample status was not received.On 15dec2020, the product quality complaint group provided the following investigation results for unknown lot.Complaint sub-class: wrap/patch/pad too hot.This investigation was conducted for an unknown lot number nsw 8hr product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass wrap/patch/pad too hot.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.Severity of harm was s3.Follow-up (03nov2020): new information received from the product quality complaint group included investigational results.Follow-up (13nov2020): new information received from the product quality complaint group included: additional investigation results.Follow-up (23nov2020): follow-up attempts completed.No further information expected.Follow-up (11dec2020): new information received from the product quality complaint group includes investigational results for complaint sub-class heat cells damaged/leaking revised from lot number dk2617 to unknown lot number and thus the investigational results removed.Trend information for complaint sub-class wrap/patch/pad too hot added.Follow-up attempts are completed.No further information is expected.Follow-up (15dec2020): new information received from product quality complaint group includes investigational results for complaint sub-class wrap/patch/pad too hot for unknown lot.Follow-up attempts are completed.No further information is expected.Follow-up (08jan2021): new information received from the product quality complaint group includes severity rating.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, 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 she "got burned." the cause of the consumer stating she "got burned" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Site sample status was not received.Complaint sub-class: wrap/patch/pad too hot.Summary of investigation: batch dk2617 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Root cause/capa: process related was no; final confirmation status was not confirmed.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 "they are burning skin." the cause of the consumer stating "they are burning skin" 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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Site sample status was not received.Complaint sub-class: wrap/patch/pad too hot for unknown lot.This investigation was conducted for an unknown lot number nsw 8hr product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass wrap/patch/pad too hot.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.
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Search Alerts/Recalls
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