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| Lot Number X96230 |
| Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Swelling (2091); Discomfort (2330); Partial thickness (Second Degree) Burn (2694)
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| Event Date 04/10/2020 |
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Event Type
Injury
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Event Description
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Burns/blisters [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot # x96230, expiration date: jul2021) from an unspecified date for lower back pain.The patient's medical history and concomitant medications were not reported.The patient reported that her partner purchased the thermacare heatwraps on (b)(6) 2020 as she had been suffering with lower back pain.She followed the instructions listed including the warnings, and after roughly 5 hours it started to feel uncomfortable and so she took it off.It has now left her with burns/ blisters on an unspecified date in (b)(6) 2020.She did understand how this was possible if left on for more then 8 hours or for an older person (over 55); however, she was (b)(6) and did not exceed the 8 hours.She noticed that it had been recalled a couple of times due to this happening.She was not sure if the one she used was recalled or not but she was not happy that this has caused her further injury to the pain she was already suffering.This had not happened to her before with this product or similar products.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the event 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 burns/ blisters as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of burns/ blisters as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term].Burns/blisters [burns second degree].Narrative: this is a spontaneous report from a contactable consumer.A 27-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot # x96230, expiration date: jul2021) from (b)(6) 2020 to (b)(6) 2020, for lower back pain.The patient's medical history was not reported.Concomitant medications included codeine phosphate, paracetamol (co-codamol) and naproxen both from (b)(6) of 2020, for lower back pain and other heat product (hot water bottle in cover) was used for around 3 hours each night on (b)(6) 2020 for 2 days.The patient reported that she had severe lower back pain on (b)(6) 2020.Due to the pandemic, she was only able to speak to her gp over the phone.Potential muscle strain/sciatica.She was advised to take codeine phosphate, paracetamol.She was still in a lot of pain on (b)(6) 2020, so spoke to a third gp and was prescribed naproxen.Her partner went to pick up the prescription and also got heat wraps.She put it on that night around 10pm.She followed the instructions listed including the warnings, and at around 3am after roughly 5 hours it started to feel uncomfortable and so she took it off.She was unaware that it had burnt her until the next time she was up at around 7.30am.It has now left her with burns/ blisters on (b)(6) 2020.The attached photo was described as blister ruptured.She did understand how this was possible if left on for more then 8 hours or for an older person (over 55); however, she was 27 and did not exceed the 8 hours.She noticed that it had been recalled a couple of times due to this happening.She was not sure if the one she used was recalled or not but she was not happy that this has caused her further injury to the pain she was already suffering.This had not happened to her before with this product or similar products.She had not been sleeping well due to the back pain and was awake many times during the night.She went to the toilet around midnight and checked her back and reapplied the heat wrap.Treatment for the event included the use of sudocrem at home.She was sleeping on an off while wearing it.The adhesive was attached to her body.She put it on at night but due to her back pain was not sleeping well.No exercise while using the product.She checked her skin once when going to the toilet and once when she removed it.The event occurred on (b)(6) 2020 and was ongoing.The remaining symptoms were painful weeping blisters.Gp was not contacted.No medical condition, skin tone fair, no sensitive skin or abnormal skin conditions.Thermacare back/hip, red box which has been disposed.Patient previously used thermacare for 1-2 days a few years prior to reporting.Action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.Clinical outcome of the event was not resolved.Additional information has been requested and will be provided as it becomes available.Follow up (16apr2020): new information received from the same contactable consumer includes: past drug effect, concomitant medications, event data (event details, updated onset date and outcome) and description of attached photo (blister ruptured)., comment: based on the information provided, the event of burns/ blisters as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Batch x96230 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.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.Conclusion: 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 caused "burns/ blisters." the cause of the consumer stating the wrap caused burns/ blisters is inconclusive since review of records does not provide evidence to support a defective product.Affiliate photos does not provide sufficient information to conclude a 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.Visual reserve sample evaluation: the visual inspection of retain samples included one carton and the two pouched wraps inside.A visual evaluation was performed to identify a potential trend on batch x96230 and the subclass adverse event/serious/unknown.A trend was not identified.On this basis, a trend does not exist for this batch.Inspection shows no obvious defects to carton or pouched wraps.
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Event Description
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Event verbatim [preferred term] , burns/blisters [burns second degree], sleeping on an off while wearing it, followed the instructions listed including the warnings [intentional device misuse], narrative: this is a spontaneous report from a contactable consumer.A 27-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot # x96230, expiration date: jul2021) from (b)(6) 2020 for lower back pain.The patient's medical history was not reported.Concomitant medications included codeine phosphate, paracetamol (co-codamol) and naproxen both from (b)(6) 2020 for lower back pain and other heat product (hot water bottle in cover) was used for around 3 hours each night on (b)(6) 2020 for 2 days.The patient reported that she had severe lower back pain on (b)(6) 2020.Due to the pandemic, she was only able to speak to her gp over the phone.Potential muscle strain/sciatica.She was advised to take codeine phosphate, paracetamol.She was still in a lot of pain on (b)(6) 2020, so spoke to a third gp and was prescribed naproxen.Her partner went to pick up the prescription and also got heatwraps.She put it on that night around 10pm.She followed the instructions listed including the warnings, and at around 3am after roughly 5 hours it started to feel uncomfortable and so she took it off.She was unaware that it had burnt her until the next time she was up at around 7.30am.It has now left her with burns/ blisters on (b)(6) 2020.The attached photo was described as blister ruptured.She did understand how this was possible if left on for more then 8 hours or for an older person (over 55); however, she was 27 and did not exceed the 8 hours.She noticed that it had been recalled a couple of times due to this happening.She was not sure if the one she used was recalled or not but she was not happy that this has caused her further injury to the pain she was already suffering.This had not happened to her before with this product or similar products.She had not been sleeping well due to the back pain and was awake many times during the night.She went to the toilet around midnight and checked her back and reapplied the heatwrap.Treatment for the event included the use of sudocrem at home.She was sleeping on an off while wearing it.The adhesive was attached to her body.She put it on at night but due to her back pain was not sleeping well.No exercise while using the product.She checked her skin once when going to the toilet and once when she removed it.The event occurred on (b)(6) 2020 and was ongoing.The remaining symptoms were painful weeping blisters.Gp was not contacted.No medical condition, skin tone fair, no sensitive skin or abnormal skin conditions.Thermacare back/hip, red box which has been disposed.Patient previously used thermacare for 1-2 days a few years prior to reporting.Action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.Clinical outcome of the event burn blister was not resolved.Clinical outcome of remaining event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Batch x96230 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.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.Conclusion: 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 caused "burns/ blisters." the cause of the consumer stating the wrap caused burns/ blisters is inconclusive since review of records does not provide evidence to support a defective product.Affiliate photos does not provide sufficient information to conclude a 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.Visual reserve sample evaluation: the visual inspection of retain samples included one carton and the two pouched wraps inside.A visual evaluation was performed to identify a potential trend on batch x96230 and the subclass adverse event/serious/unknown.A trend was not identified.On this basis, a trend does not exist for this batch.Inspection shows no obvious defects to carton or pouched wraps.Follow-up (16apr2020): new information received from the same contactable consumer includes: past drug effect, concomitant medications, event data (event details, updated onset date and outcome) and description of attached photo (blister ruptured).Follow-up (28may2020): new information received from product quality complaints (pqc) group included: pq investigation results and reaction data (additional event of intentional device misuse).No follow-up attempts are possible.No further information is expected., comment: based on the information provided, the event of burns/ blisters as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Batch x96230 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.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.Conclusion: 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 caused "burns/ blisters." the cause of the consumer stating the wrap caused burns/ blisters is inconclusive since review of records does not provide evidence to support a defective product.Affiliate photos does not provide sufficient information to conclude a 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.Visual reserve sample evaluation: the visual inspection of retain samples included one carton and the two pouched wraps inside.A visual evaluation was performed to identify a potential trend on batch x96230 and the subclass adverse event/serious/unknown.A trend was not identified.On this basis, a trend does not exist for this batch.Inspection shows no obvious defects to carton or pouched wraps.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wrap "started to feel uncomfortable." the cause of the consumer reporting wrap "started to feel uncomfortable" is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment wrap/patch/pad too hot x96230.On this basis, a trend does not exist for this batch.Site sample status: photos received.Attached photo: 1 carton: (l) x96230 08/28; exp 2021-07 08:24; no wrap or pouch shown in attached photo.Exped trend actions taken:there was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.
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Event Description
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Event verbatim [preferred term].Sleeping on an off while wearing it, followed the instructions listed including the warnings [intentional device misuse], burns/blisters [burns second degree], , narrative: this is a spontaneous report from a contactable consumer.A 27-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot # x96230, expiration date: jul2021) from (b)(6) 2020 to (b)(6) 2020 for lower back pain.The patient's medical history was not reported.Concomitant medications included codeine phosphate, paracetamol (co-codamol) and naproxen both from (b)(6) 2020 for lower back pain and other heat product (hot water bottle in cover) was used for around 3 hours each night on (b)(6) 2020 for 2 days.Patient previously used thermacare for 1-2 days a few years prior to reporting.The patient reported that she had severe lower back pain on (b)(6) 2020.Due to the pandemic, she was only able to speak to her gp over the phone.Potential muscle strain/sciatica.She was advised to take codeine phosphate, paracetamol.She was still in a lot of pain on (b)(6) 2020, so spoke to a third gp and was prescribed naproxen.Her partner went to pick up the prescription and also got heatwraps.She put it on that night around 10pm.She followed the instructions listed including the warnings, and at around 3am after roughly 5 hours it started to feel uncomfortable and so she took it off.She was unaware that it had burnt her until the next time she was up at around 7.30am.It has now left her with burns/ blisters on (b)(6) 2020.The attached photo was described as blister ruptured.She did understand how this was possible if left on for more then 8 hours or for an older person (over 55); however, she was 27 and did not exceed the 8 hours.She noticed that it had been recalled a couple of times due to this happening.She was not sure if the one she used was recalled or not but she was not happy that this has caused her further injury to the pain she was already suffering.This had not happened to her before with this product or similar products.She had not been sleeping well due to the back pain and was awake many times during the night.She went to the toilet around midnight and checked her back and reapplied the heatwrap.Treatment for the event included the use of sudocrem at home.She was sleeping on an off while wearing it.The adhesive was attached to her body.She put it on at night but due to her back pain was not sleeping well.No exercise while using the product.She checked her skin once when going to the toilet and once when she removed it.The event occurred on (b)(6) 2020 and was ongoing.The remaining symptoms were painful weeping blisters.Gp was not contacted.No medical condition, skin tone fair, no sensitive skin or abnormal skin conditions.Thermacare back/hip, red box which has been disposed.Action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2020.Clinical outcome of the event burn blister was not resolved.Clinical outcome of remaining event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Batch x96230 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.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.Conclusion: 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 caused "burns/ blisters." the cause of the consumer stating the wrap caused burns/ blisters is inconclusive since review of records does not provide evidence to support a defective product.Affiliate photos does not provide sufficient information to conclude a 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.Visual reserve sample evaluation: the visual inspection of retain samples included one carton and the two pouched wraps inside.A visual evaluation was performed to identify a potential trend on batch x96230 and the subclass adverse event/serious/unknown.A trend was not identified.On this basis, a trend does not exist for this batch.Inspection shows no obvious defects to carton or pouched wraps.According to the product quality complaint group on (b)(6) 2020: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wrap "started to feel uncomfortable." the cause of the consumer reporting wrap "started to feel uncomfortable" is inconclusive.The review of records does not provide evidence to support the defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending chart attachment wrap/patch/pad too hot x96230.On this basis, a trend does not exist for this batch.Site sample status: photos received.Attached photo: 1 carton: (l) x96230 08/28; exp 2021-07 08:24; no wrap or pouch shown in attached photo.Exped trend actions taken:there was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.Follow-up (16apr2020): new information received from the same contactable consumer includes: past drug effect, concomitant medications, event data (event details, updated onset date and outcome) and description of attached photo (blister ruptured).Follow-up (28may2020): new information received from product quality complaints (pqc) group included: pq investigation results and reaction data (additional event of intentional device misuse).No follow-up attempts are possible.No further information is expected.Follow up (12oct2020): new information received from the product quality complaint group included additional investigational results and updated trending information.
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Search Alerts/Recalls
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