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| Lot Number L70514 |
| Device Problems
Insufficient Heating (1287); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Inadequate Pain Relief (2388); Burn, Thermal (2530)
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| Event Date 06/24/2015 |
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Event Type
Injury
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Event Description
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She got burnt on her right lower back in the shape of the heat cell [thermal burn].Did not check skin under heatwrap during use (device misuse].Wrap did not relieve her back nerve pain [device ineffective].This is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) african american female patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot#: l70514, expiration date: feb2018) from (b)(6) 2015 for back pain relief.Medical history included ongoing spondylitis, nerve decompression from (b)(6) 2013, walking disability(cannot walk; especially in the morning l4-l5 because of the nerves) and this year it became progressively worse since (b)(6) 2015 and ongoing, osteoarthritis, pain from an unknown date and unknown if ongoing taking narco and neuralgia from an unknown date and unknown if ongoing taking gabapentin/neurontin.The patient is currently under the care of an orthopedic surgeon and a neuro surgeon.Concomitant medications included hydrocodone bitartrate, paracetamol (narco) 10/325 mg every 6 hours for pain and gabapentin (neurontin) 2/300 mg three times daily" for nerve pain.Past product history included thermacare heatwraps (thermacare heatwraps) for an unspecified date for an unspecified indication and experienced no adverse event and lyrica from an unspecified date in 2013; (reported as 2 years) for "numbing the nerve", permanently discontinued on an unspecified date and experienced drug ineffective.On (b)(6) 2015, the patient reported she had the heatwrap on driving home and kept feeling a stinging sensation like something was rubbing her underwear.When she removed her jeans, she realized she got burnt.The heatwrap had been adhered to her underwear and not directly to her skin.She stated she knew her skin was not broken before she used the product.The burn was in the shape of the heat cell on the wrap, located on her right lower back and was experienced after using the heatwrap for approximately 5 hours.She stated the burn stings and is extremely painful.The patient had to put a band-aid over it because she can't stand anything rubbing up against it.She applied bacitracin to the burn.The patient reported she did not know the degree of the burn.She stated the heatwrap was not that hot; her heating pad is hotter than the wrap.The patient mentioned the heatwrap did not relieve her back pain.She reported with her back medical history, she needs to have surgery for spinal fusion and they may not do her back surgery if the burn is not healed before (b)(6) 2015.Therapeutic measures were taken as a result of she got burnt on her right lower back (thermal burn).The patient assessed her skin tone as chocolate.The patient stated she did not have sensitive skin or any skin disorders.She did not exercise while using the heatwrap and read the usage instructions prior to using the heatwrap.The patient reported she did not check the skin under the heatwrap while wearing the product.She did not use any creams, lotions or gels under the wrap.The patient previously used a heating pad for pain relief for 10 to 15 minutes at a time and never experienced an adverse effect.Action taken with the product was permanently withdrawn on (b)(6) 2015.Therapeutic measures taken included a band-aid and bacitracin ointment applied to the burn.At the time of the report, clinical outcome of the event was not resolved.Additional information has been requested and will be provided as it becomes available.Based on the information provided, the event thermal burn with device misuse as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with he use of the device.The event device ineffective is assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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Required intervention.
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Event Description
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She got burnt on her right lower back in the shape of the heat cell/2nd degree burn to her back.Did not check skin under heatwrap during use.Wrap did not relieve her back nerve pain.Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot #: l70514, expiration date: feb2018) from (b)(6) 2015 for back pain relief.Medical history included ongoing spondylitis, nerve decompression from (b)(6) 2013, walking disability (cannot walk especially in the morning- l4-l5 because of the nerves) and this year it became progressively worse since (b)(6) 2015 and ongoing, ongoing osteoarthritis, pain from an unknown date and unknown if ongoing taking narco and nerve pain from an unknown date and unknown if ongoing taking gabapentin /neurontin.The patient is currently under the care of an orthopedic surgeon and a neuro surgeon.Concomitant medications included hydrocodone bitartrate, paracetamol (norco) 10/325 mg every 6 hours for pain and gabapentin (neurontin) 2x300 mg three times daily for nerve pain.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication and experienced no adverse event and lyrica from an unspecified date in 2013 (reported as 2 years) for "numbing the nerve", permanently discontinued on an unspecified date and experienced drug ineffective.On 24jun2015, the patient reported she had the heatwrap on driving home and kept feeling a stinging sensation like something was rubbing over her underwear.When she removed her jeans, she realized she got burnt.The heatwrap had been adhered to her underwear and not directly to her skin.She stated she knew her skin was not broken before she used the product.The burn was in the shape of the heat cell on the wrap, located on her right lower back and was experienced after using the heatwrap for approximately 5 hours.She stated the burn stings and is extremely painful.The patient had to put a band-aid over it because she can't stand anything rubbing up against it.She applied bacitracin to the burn.The patient reported it was second degree burn on her back.She stated the heatwrap was not that hot, her heating pad is hotter than the wrap.The patient mentioned the heatwrap did not relieve her back pain.She reported with her back medical history she needs to have surgery for spinal fusion and they may not do her back surgery if the burn is not healed before (b)(6) 2015.The patient assessed her skin tone as chocolate.The patient stated she did not have sensitive skin or any other skin disorders.She did not exercise while using the heatwrap and read the usage instructions prior to using the heatwrap.The patient reported she did not check the skin under the heatwrap while wearing the product.She did not use any creams, lotions or gels under the wrap.The patient previously used a heating pad for pain relief for 10 to 15 minutes at a time and never experienced an adverse effect.Action taken with the product was permanently withdrawn on (b)(6) 2015.Therapeutic measures taken included a band-aid and bacitracin ointment applied to the burn.At the time of the report, clinical outcome of the event was not resolved.As of 19aug2015, the product quality complaint (pqc) group investigation results stated that the evaluation of one retain shows no obvious defects.On the basis of this evaluation, a trend does not exist for this batch; therefore there is no further action required at this time.Review of the batch device history record for lot l70514 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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the seven day run reports a total of 288 wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap did not relieve her back nerve pain.The cause of the alleged no relief is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (09jul2015): new information reported from a contactable consumer includes: update event burn to 2nd degree burn.Follow-up (19aug2015): new information reported from the pqc group includes: product investigation summary results.Follow-up (14oct2015): follow-up attempts completed.No further information expected.Follow-up (03nov2015): new information received from a contactable physician included the patient did not provide information to him/her regarding the reported events and the physician did not treat this problem.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the event burn second degree as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events device ineffective and device misuse are assessed as associated with the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event burn second degree as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events device ineffective and device misuse are assessed as associated with the device.This case meets final 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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Follow-up (july 9, 201 5).New information reported from a contactable consumer includes- update event burn to 2nd degree burn.
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Manufacturer Narrative
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The evaluation of one retain shows no obvious defects.On the basis of this evaluation, a trend does not exist for this batch; therefore there is no further action required at this time.Review of the batch device history record for lot l70514 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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the seven day run reports a total of (b)(4) wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap did not relieve her back nerve pain.The cause of the alleged no relief is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer.A (b)(6) year-old (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot #: l70514, expiration date: feb2018) from (b)(6) 2015 for back pain relief.Medical history included ongoing spondylitis, nerve decompression from (b)(6) 2013, walking disability (cannot walk especially in the morning- l4-l5 because of the nerves) and this year it became progressively worse since (b)(6) 2015 and ongoing, ongoing osteoarthritis, pain from an unknown date and unknown if ongoing taking narco and nerve pain from an unknown date and unknown if ongoing taking gabapentin / neurontin.The patient is currently under the care of an orthopedic surgeon and a neuro surgeon.Concomitant medications included hydrocodone bitartrate, paracetamol (norco) 10/325 mg every 6 hours for pain and gabapentin (neurontin) 2x300 mg three times daily for nerve pain.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication and experienced no adverse event and lyrica from an unspecified date in 2013 (reported as 2 years) for "numbing the nerve", permanently discontinued on an unspecified date and experienced drug ineffective.On (b)(6) 2015, the patient reported she had the heatwrap on driving home and kept feeling a stinging sensation like something was rubbing over her underwear.When she removed her jeans, she realized she got burnt.The heatwrap had been adhered to her underwear and not directly to her skin.She stated she knew her skin was not broken before she used the product.The burn was in the shape of the heat cell on the wrap, located on her right lower back and was experienced after using the heatwrap for approximately 5 hours.She stated the burn stings and is extremely painful.The patient had to put a band-aid over it because she can't stand anything rubbing up against it.She applied bacitracin to the burn.The patient reported it was second degree burn on her back.She stated the heatwrap was not that hot, her heating pad is hotter than the wrap.The patient mentioned the heatwrap did not relieve her back pain.She reported with her back medical history she needs to have surgery for spinal fusion and they may not do her back surgery if the burn is not healed before (b)(6) 2015.The patient assessed her skin tone as chocolate.The patient stated she did not have sensitive skin or any other skin disorders.She did not exercise while using the heatwrap and read the usage instructions prior to using the heatwrap.The patient reported she did not check the skin under the heatwrap while wearing the product.She did not use any creams, lotions or gels under the wrap.The patient previously used a heating pad for pain relief for 10 to 15 minutes at a time and never experienced an adverse effect.Action taken with the product was permanently withdrawn on (b)(6) 2015.Therapeutic measures taken included a band-aid and bacitracin ointment applied to the burn.At the time of the report, clinical outcome of the event was not resolved.As of 19aug2015, the product quality complaint (pqc) group investigation results stated that the evaluation of one retain shows no obvious defects.On the basis of this evaluation, a trend does not exist for this batch; therefore there is no further action required at this time.Review of the batch device history record for lot l70514 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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the seven day run reports a total of (b)(4) wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap did not relieve her back nerve pain.The cause of the alleged no relief is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (09jul2015): new information reported from a contactable consumer includes: update event burn to 2nd degree burn.Follow-up (19aug2015): new information reported from the pqc group includes: product investigation summary results.Company clinical evaluation comment: based on the information provided, the event burn second degree as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events device ineffective and device misuse are assessed as associated with the device.This case meets follow up10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event burn second degree as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events device ineffective and device misuse are assessed as associated with the device.This case meets follow up10-day eu and 30-day fda reportability.Evaluation summary: the evaluation of one retain shows no obvious defects.On the basis of this evaluation, a trend does not exist for this batch; therefore there is no further action required at this time.Review of the batch device history record for lot l70514 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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the seven day run reports a total of (b)(4) wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap did not relieve her back nerve pain.The cause of the alleged no relief is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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Event verbatim [preferred term].Did not check skin under heatwrap during use [intentional device misuse], stinging sensation/ she got burnt on her right lower back in the shape of the heat cell/the burn stings and is extremely painful/2nd degree burn to her back [burns second degree], wrap did not relieve her back nerve pain [device ineffective], the heatwrap was not that hot, her heating pad is hotter than the wrap [device issue], narrative: this is a spontaneous report from a contactable consumer.A 58-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot #: l70514, expiration date: feb2018) from (b)(6) 2015 for back pain relief.Medical history included ongoing spondylitis, nerve decompression from (b)(6) 2013 and unknown if ongoing, cannot walk (especially in the morning- l4-l5 because of the nerves) and this year it became progressively worse since (b)(6) 2015 and ongoing, ongoing osteoarthritis, pain (taking narco) and nerve pain (taking gabapentin /neurontin).The patient is currently under the care of an orthopedic surgeon and a neuro surgeon.Concomitant medications included hydrocodone bitartrate, paracetamol (norco) 10/325 mg every 6 hours for pain and gabapentin (neurontin) 2x300 mg three times daily for nerve pain.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication and experienced no adverse event and pregabalin (lyrica) from an unspecified date in 2013 (reported as 2 years) for "numbing the nerve", permanently discontinued on an unspecified date and experienced didn't do anything.On (b)(6) 2015, the patient reported she had the heatwrap on driving home and kept feeling a stinging sensation like something was rubbing over her underwear.When she removed her jeans, she realized she got burnt.The heatwrap had been adhered to her underwear and not directly to her skin.She stated she knew her skin was not broken before she used the product.The burn was in the shape of the heat cell on the wrap, located on her right lower back and was experienced after using the heatwrap for approximately 5 hours.She stated the burn stings and is extremely painful.The patient had to put a band-aid over it because she can't stand anything rubbing up against it.She applied bacitracin to the burn.The patient reported it was second degree burn on her back.She stated the heatwrap was not that hot, her heating pad is hotter than the wrap.The patient mentioned the heatwrap did not relieve her back pain.She reported with her back medical history she needs to have surgery for spinal fusion and they may not do her back surgery if the burn is not healed before (b)(6) 2015.The patient assessed her skin tone as chocolate.The patient stated she did not have sensitive skin or any other skin disorders.She did not exercise while using the heatwrap and read the usage instructions prior to using the heatwrap.The patient reported she did not check the skin under the heatwrap while wearing the product.She did not use any creams, lotions or gels under the wrap.The patient previously used a heating pad for pain relief for 10 to 15 minutes at a time and never experienced an adverse effect.Action taken with the product was permanently withdrawn on (b)(6) 2015.Therapeutic measures taken included a band-aid and bacitracin ointment applied to the burn.At the time of the report, clinical outcome of the event burns second degree was not resolved, of the other events was unknown.As of 19aug2015, the product quality complaint (pqc) group investigation results stated that the evaluation of one retain shows no obvious defects.On the basis of this evaluation, a trend does not exist for this batch; therefore there is no further action required at this time.Review of the batch device history record for lot l70514 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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the seven day run reports a total of 288 wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap did not relieve her back nerve pain.The cause of the alleged no relief is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.According to product quality complaints on 17jul2020, batch l70514 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 stated, "she got burnt." the cause consumer reporting "she got burnt" 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 at the time this investigation was written has expired.Expiry date was feb2018.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 second complaint about the subclass adverse event safety request for investigation defect received at the (site name), requiring evaluation for this batch.The previous complaint was not confirmed to have a manufacturing-related root cause for the complaint.The complaint evaluated to identify any potential trend.Based on this evaluation, a trend does not exist for this batch.Site sample status: not received.Follow-up (09jul2015): new information reported from a contactable consumer includes: update event burn to 2nd degree burn.Follow-up (19aug2015): new information reported from the pqc group includes: product investigation summary results.Follow-up (14oct2015): follow-up attempts completed.No further information expected.Follow-up (03nov2015): new information received from a contactable physician included the patient did not provide information to him/her regarding the reported events and the physician did not treat this problem.Follow-up attempts completed.No further information expected.Follow-up (17jul2020): new information received from product quality complaints included: investigation result.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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The evaluation of one retain shows no obvious defects.On the basis of this evaluation, a trend does not exist for this batch; therefore there is no further action required at this time.Review of the batch device history record for lot l70514 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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the seven day run reports a total of 288 wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap did not relieve her back nerve pain.The cause of the alleged no relief is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Batch l70514 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 stated, "she got burnt." the cause consumer reporting ¿she got burnt¿ 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 at the time this investigation was written has expired.Expiry date was feb2018.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 second complaint about the subclass adverse event safety request for investigation defect received at the (site name), requiring evaluation for this batch.The previous complaint was not confirmed to have a manufacturing-related root cause for the complaint.The complaint evaluated to identify any potential trend.Based on this evaluation, a trend does not exist for this batch.Site sample status: not received.
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Search Alerts/Recalls
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