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| Lot Number R08719 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)
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| Patient Problems
Burning Sensation (2146); Sweating (2444); Partial thickness (Second Degree) Burn (2694)
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| Event Date 02/06/2019 |
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Event Type
Injury
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Event Description
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After 90 minutes of running the patient had burns over the whole area of the wrap, with numerous blisters [burns second degree], had noticed that the wrap was very hot, and that it was burning unpleasantly [device issue], did not read the usage instructions before /wearing several layers of clothes over the thermacare, did not check the skin under it, engaged in exercise while using the product [device use error], sweating [hyperhidrosis].Case narrative: this is a spontaneous report from a pfizer sponsored program brand websites for division consumer healthcare (b)(6) from a contactable consumer reported for herself.A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number r08719, expiration date jun2019, from (b)(6) 2019 at 16:30 to (b)(6) 2019 at 18:00 for 1.5 hours for tension in shoulder girdle, causing problems at running.The patient medical history included ongoing rather sensitive skin.The patient was currently not under the care of a physician for any medical condition, not pregnant and was not taking any medication during the time the problem was experienced.The patient has very light or fair skin tone and rather sensitive skin, but no abnormal skin conditions.There were no concomitant medications.The patient had previously already used thermacare heatwraps and other heat products for pain relief (latter 1-2 years ago) and had not previously experienced a problem/symptom with thermacare or any other of these products.The patient used thermacare heat wrap, purchased in red box, lot number r08719, expiration date jun2019.The patient had used a thermacare heat wrap 12 days ago (on (b)(6) 2019), because she had tension in shoulder girdle, which hampered her during running.As she had used thermacare already several times in the last years (in 2018), she knew that she tolerated the heat wraps well.But not this time.She did not know, whether the combination of thermacare with wet skin or saltiness on the skin, lead to the burns on (b)(6) 2019 18:00.The fact was that after 90 minutes of running she had burns over the whole area of the heat wrap, which only now started to heal slowly.She sent a photo, that showed burns with numerous blisters 4 days after and reddening of the skin.She did not know if such a problem existed in general.In her opinion, the risk potential in connection with sport should be better pointed out.While wearing thermacare, the patient attached the adhesive to body, was wearing several layers of clothing over the thermacare product (no belt, no direct pressure to the product) and engaged in exercise (running 1.5 hours).The patient did not check her skin under the product while wearing thermacare and did not read the usage instructions before she used the product.After about 20 minutes of running the feeling changed from "pleasantly warm" to "it burns quite unpleasantly", it was unpleasant burning, but no severe pain.The pain started probably together with starting of sweating.The patient stated as soon as she started to sweat, she had noticed that the wrap was very hot, and that it was burning unpleasantly.The unpleasant feeling remained the same, did not become stronger.As she was alone and outdoors, she could not put off the clothes and check.Based on the burning feeling, she assumed, that the affected area for sure would be red, but she did not suppose the burns, otherwise she would have reacted.She stated that it was like this, that during running one focused on other things.If she was sitting on a couch at home, she would probably be more aware of the pain.She assumed that the problems are in the combination of the heat wrap and sweat (warmth, salt, moisture).The patient reported burns with blisters, starting on the (b)(6) 2019 18:00 (after sport exercise), blisters were healing currently, had not disappeared completely yet, were strongly seen about 7 days.The patient did not consult a healthcare professional for the problem/symptoms.The action taken in response to the event for thermacare heatwrap was stopped on (b)(6) 2019 at 18:00.The treatment included disinfection, special honey adhesive pads, day 1-2 betadine, thereafter bepanthen, now calendula ointment.The outcome of burns with blisters and had noticed that the wrap was very hot, and that it was burning unpleasantly was recovering.The outcome of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of burns second degree, device issue and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event hyperhidrosis is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] after 90 minutes of running the patient had burns over the whole area of the wrap, with numerous blisters [burns second degree] , had noticed that the wrap was very hot, and that it was burning unpleasantly [device issue] , did not read the usage instructions before did not check the skin under it, engaged in exercise while using the product [device use error] , sweating [hyperhidrosis] ,.Case narrative:this is a spontaneous report from a pfizer sponsored program brand websites for division consumer healthcare austria from a contactable consumer reported for herself.A 42-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number r08719, expiration date jun2019, from 06feb2019 at 16:30 to 06feb2019 at 18:00 for 1.5 hours for tension in shoulder girdle, causing problems at running.The patient medical history included ongoing rather sensitive skin.The patient was currently not under the care of a physician for any medical condition, not pregnant and was not taking any medication during the time the problem was experienced.The patient has very light or fair skin tone and rather sensitive skin, but no abnormal skin conditions.There were no concomitant medications.The patient had previously already used thermacare heatwraps and other heat products for pain relief (latter 1-2 years ago) and had not previously experienced a problem/symptom with thermacare or any other of these products.The patient used thermacare heat wrap, purchased in red box, lot number r08719, expiration date jun2019.The patient had used a thermacare heat wrap 12 days ago (on 06feb2019), because she had tension in shoulder girdle, which hampered her during running.As she had used thermacare already several times in the last years, she knew that she tolerated the heat wraps well.But not this time.She did not know, whether the combination of thermacare with wet skin or saltiness on the skin, lead to the burns on 06feb2019 18:00.The fact was that after 90 minutes of running she had burns over the whole area of the heat wrap, which only now started to heal slowly.She sent a photo, that showed burns with numerous blisters 4 days after and reddening of the skin.She did not know if such a problem existed in general.In her opinion, the risk potential in connection with sport should be better pointed out.While wearing thermacare, the patient attached the adhesive to body, was wearing several layers of clothing over the thermacare product (no belt, no direct pressure to the product) and engaged in exercise (running 1.5 hours).The patient did not check her skin under the product while wearing thermacare and did not read the usage instructions before she used the product.After about 20 minutes of running the feeling changed from "pleasantly warm" to "it burns quite unpleasantly", it was unpleasant burning, but no severe pain.The pain started probably together with starting of sweating.The patient stated as soon as she started to sweat, she had noticed that the wrap was very hot, and that it was burning unpleasantly.The unpleasant feeling remained the same, did not become stronger.As she was alone and outdoors, she could not put off the clothes and check.Based on the burning feeling, she assumed, that the affected area for sure would be red, but she did not suppose the burns, otherwise she would have reacted.She stated that it was like this, that during running one focused on other things.If she was sitting on a couch at home, she would probably be more aware of the pain.She assumed that the problems are in the combination of the heat wrap and sweat (warmth, salt, moisture).The patient reported burns with blisters, starting on the 06feb2019 18:00 (after sport exercise), blisters were healing currently, had not disappeared completely yet, were strongly seen about 7 days.The patient did not consult a healthcare professional for the problem/symptoms.On 12mar2019, the consumer reported, "attached i am sending an actual photograph.You can see two big areas, where scars could remain and additionally some spots.In total the skin is very red and not beautiful - what is not normal.Normally i have quite a beautiful skin.I was jogging, so i trained sports and therefore i sweat quite a lot.As soon as i returned home after 1.5 hours, i stopped sweating.In my opinion, there was a relationship between the sweating and the burn." the patient reported the it appears that scars will remain on her neck.The action taken in response to the events for thermacare heatwrap was stopped on 06feb2019 at 18:00.The treatment included desinfection, special honey adhesive pads, day 1-2 betadona, therafter bepanthen, now calendula ointment.The outcome of burns with blisters and had noticed that the wrap was very hot, and that it was burning unpleasantly was recovering.The outcome of sweating was resolved in 2019.The outcome of remaining events, was unknown.According to product quality complaint group on 22feb2019: batch r08719 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and shows no obvious defect.An evaluation of the complaint history confirms that this is the first complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of five complaints for flex use xl products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of too hot.Based on this pcom search for the subclass of too hot for flex use xl products the data did not show an increase over time (24 months).There is not a trend identified for the subclass too hot for flex use products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defect recorded for the batch.There was one wrap attribute defect recorded for a dead cell (individual cell not dosed with brine will not heat up).A brine pump was replaced to correct the dead cell.The individual dead cell did not affect the overall wrap average temperature causing it to be outside of the wrap average temperature specification.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degrees c - 41.6 degrees c).The shiftly production transition notes were reviewed.Other than the incident with a dead cell found during in process wrap attribute testing, there were no other incidents noted during manufacturing in the heat pack making portion of the line that would affect wrap temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures being outside of the required in process temperature specifications.Investigation summary: after a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she was wearing the wrap "for 90-minutes during jogging session" and "had an uncomfortable burning sensation on the skin under the patch." the cause of the burning sensation is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device; following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.According to product quality complaint group on 20mar2019, a site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.The severity ranking can not be assigned for a "too hot" complaint.The review of production records show no issues with thermal results for the batch, there was not a product quality complaint mentioned in the intake information.The sample is not available for evaluation by the site, a device malfunction cannot be confirmed.Follow-up (22feb2019): new information received from product quality complaint group includes investigation results.Follow-up (12mar2019 and 20mar2019): new information from the same consumer includes: updated event outcome of sweating, added other details.In addition, new information received from product quality complaint group includes additional investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (21may2019): new information received from the consumer included: event data (outcome updated)., comment: based on the information provided, the events of burns second degree, device issue and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event hyperhidrosis is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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According to product quality complaint group on (b)(6) 2019: batch r08719 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and shows no obvious defect.An evaluation of the complaint history confirms that this is the first complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of five complaints for flex use xl products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of too hot.Based on this pcom search for the subclass of too hot for flex use xl products the data did not show an increase over time (24 months).There is not a trend identified for the subclass too hot for flex use products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defect recorded for the batch.There was one wrap attribute defect recorded for a dead cell (individual cell not dosed with brine will not heat up).A brine pump was replaced to correct the dead cell.The individual dead cell did not affect the overall wrap average temperature causing it to be outside of the wrap average temperature specification.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degrees c - 41.6 degrees c).The shiftly production transition notes were reviewed.Other than the incident with a dead cell found during in process wrap attribute testing, there were no other incidents noted during manufacturing in the heat pack mak.
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Event Description
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Event verbatim [preferred term] after 90 minutes of running the patient had burns over the whole area of the wrap, with numerous blisters [burns second degree] , had noticed that the wrap was very hot, and that it was burning unpleasantly [device issue] , did not read the usage instructions before did not check the skin under it, engaged in exercise while using the product [device use error] , sweating [hyperhidrosis] ,.Case narrative:this is a spontaneous report from a pfizer sponsored program brand websites for division consumer healthcare austria from a contactable consumer reported for herself.A 42-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number r08719, expiration date jun2019, from 06feb2019 at 16:30 to 06feb2019 at 18:00 for 1.5 hours for tension in shoulder girdle, causing problems at running.The patient medical history included ongoing rather sensitive skin.The patient was currently not under the care of a physician for any medical condition, not pregnant and was not taking any medication during the time the problem was experienced.The patient has very light or fair skin tone and rather sensitive skin, but no abnormal skin conditions.There were no concomitant medications.The patient had previously already used thermacare heatwraps and other heat products for pain relief (latter 1-2 years ago) and had not previously experienced a problem/symptom with thermacare or any other of these products.The patient used thermacare heat wrap, purchased in red box, lot number r08719, expiration date jun2019.The patient had used a thermacare heat wrap 12 days ago (on 06feb2019), because she had tension in shoulder girdle, which hampered her during running.As she had used thermacare already several times in the last years, she knew that she tolerated the heat wraps well.But not this time.She did not know, whether the combination of thermacare with wet skin or saltiness on the skin, lead to the burns on (b)(6) 2019 18:00.The fact was that after 90 minutes of running she had burns over the whole area of the heat wrap, which only now started to heal slowly.She sent a photo, that showed burns with numerous blisters 4 days after and reddening of the skin.She did not know if such a problem existed in general.In her opinion, the risk potential in connection with sport should be better pointed out.While wearing thermacare, the patient attached the adhesive to body, was wearing several layers of clothing over the thermacare product (no belt, no direct pressure to the product) and engaged in exercise (running 1.5 hours).The patient did not check her skin under the product while wearing thermacare and did not read the usage instructions before she used the product.After about 20 minutes of running the feeling changed from "pleasantly warm" to "it burns quite unpleasantly", it was unpleasant burning, but no severe pain.The pain started probably together with starting of sweating.The patient stated as soon as she started to sweat, she had noticed that the wrap was very hot, and that it was burning unpleasantly.The unpleasant feeling remained the same, did not become stronger.As she was alone and outdoors, she could not put off the clothes and check.Based on the burning feeling, she assumed, that the affected area for sure would be red, but she did not suppose the burns, otherwise she would have reacted.She stated that it was like this, that during running one focused on other things.If she was sitting on a couch at home, she would probably be more aware of the pain.She assumed that the problems are in the combination of the heat wrap and sweat (warmth, salt, moisture).The patient reported burns with blisters, starting on the (b)(6) 2019 18:00 (after sport exercise), blisters were healing currently, had not disappeared completely yet, were strongly seen about 7 days.The patient did not consult a healthcare professional for the problem/symptoms.On 12mar2019, the consumer reported, "attached i am sending an actual photograph.You can see two big areas, where scars could remain and additionally some spots.In total the skin is very red and not beautiful - what is not normal.Normally i have quite a beautiful skin.I was jogging, so i trained sports and therefore i sweat quite a lot.As soon as i returned home after 1.5 hours, i stopped sweating.In my opinion, there was a relationship between the sweating and the burn." the patient reported the it appears that scars will remain on her neck.The action taken in response to the events for thermacare heatwrap was stopped on 06feb2019 at 18:00.The treatment included desinfection, special honey adhesive pads, day 1-2 betadona, therafter bepanthen, now calendula ointment.The outcome of burns with blisters and had noticed that the wrap was very hot, and that it was burning unpleasantly was recovering.The outcome of sweating was resolved in 2019.The outcome of remaining events, was unknown.According to product quality complaint group on 22feb2019: batch r08719 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and shows no obvious defect.An evaluation of the complaint history confirms that this is the first complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of five complaints for flex use xl products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of too hot.Based on this pcom search for the subclass of too hot for flex use xl products the data did not show an increase over time (24 months).There is not a trend identified for the subclass too hot for flex use products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defect recorded for the batch.There was one wrap attribute defect recorded for a dead cell (individual cell not dosed with brine will not heat up).A brine pump was replaced to correct the dead cell.The individual dead cell did not affect the overall wrap average temperature causing it to be outside of the wrap average temperature specification.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degrees c - 41.6 degrees c).The shiftly production transition notes were reviewed.Other than the incident with a dead cell found during in process wrap attribute testing, there were no other incidents noted during manufacturing in the heat pack making portion of the line that would affect wrap temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures being outside of the required in process temperature specifications.Investigation summary: after a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she was wearing the wrap "for 90-minutes during jogging session" and "had an uncomfortable burning sensation on the skin under the patch." the cause of the burning sensation is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device; following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.According to product quality complaint group on 20mar2019, a site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.The severity ranking can not be assigned for a "too hot" complaint.The review of production records show no issues with thermal results for the batch, there was not a product quality complaint mentioned in the intake information.The sample is not available for evaluation by the site, a device malfunction cannot be confirmed.According to product quality complaint group on 28may2019, sample information received.Investigation summary: the root cause category is non assignable (complaint no confirmed as a quality defect).Complaint is the result of an adverse event (a burn).The cause of the burn is inconclusive since review of records do not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch form 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 (22feb2019): new information received from product quality complaint group includes investigation results.Follow-up (12mar2019 and 20mar2019): new information from the same consumer includes: updated event outcome of sweating, added other details.In addition, new information received from product quality complaint group includes additional investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (21may2019): new information received from the consumer included: event data (outcome updated).Follow-up (29may2019): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the events of burns second degree, device issue and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event hyperhidrosis is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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According to product quality complaint group on 22feb2019: batch r08719 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and shows no obvious defect.An evaluation of the complaint history confirms that this is the first complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of five complaints for flex use xl products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of too hot.Based on this pcom search for the subclass of too hot for flex use xl products the data did not show an increase over time (24 months).There is not a trend identified for the subclass too hot for flex use products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defect recorded for the batch.There was one wrap attribute defect recorded for a dead cell (individual cell not dosed with brine will not heat up).A brine pump was replaced to correct the dead cell.The individual dead cell did not affect the overall wrap average temperature causing it to be outside of the wrap average temperature specification.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degrees c - 41.6 degrees c).The shiftly production transition notes were reviewed.Other than the incident with a dead cell found during in process wrap attribute testing, there were no other incidents noted during manufacturing in the heat pack mak.
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Event Description
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Event verbatim [preferred term] burn blisters [burns second degree] ,.Case narrative: this is a spontaneous report from a contactable consumer.A 47-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration on (b)(6) 2019 at 1 patch for back pain.The patient medical history included type i diabetes mellitus.Concomitant medication included insulin since 1999 and ongoing.Thermacare was used previously (in (b)(6) 2018 for four days) without problems.Other warming products (not further specified) were used as well in (b)(6) 2018 for one week and were tolerated well.The patient experienced burn blisters on (b)(6) 2019.The patient reported: "after applying the patch blisters have formed after about 4 hours, which are filled with water.One has already burst!!!" the patient was not pregnant and not climacteric.The patient had light skin, not sensitive, had no skin diseases.Thermacare (formulation for back, no lot number provided) was used on (b)(6) 2019 for 5 hours directly on skin, with trousers over it.Event started at 11:00.Event was described as "three big burn blisters.Two of them already resolved, the big one was still present with crust.Wound dressing was applied, inability to work for two days".Treatment (wound care) was received.The skin was controlled during use of thermacare ("once because of burning, the wrap directly removed").Further description of the event: "burn blisters appeared, large wounds, also when the wrap was removed".The was noticed after five hours.The action taken in response to the event for thermacare heatwrap was permanently discontinued on (b)(6) 2019.The outcome of the event was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (25feb2019): new information received from the contactable consumer included: suspect product data (trade name, stop date, action taken, deletion of lot number and expiration date), medical history, concomitant medication, past product history, and treatment received.Company clinical evaluation comment: based on the information provided, the event burns second degree 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., comment: based on the information provided, the event burns second degree 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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According to product quality complaint group on 22feb2019: batch r08719 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and shows no obvious defect.An evaluation of the complaint history confirms that this is the first complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of five complaints for flex use xl products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of too hot.Based on this pcom search for the subclass of too hot for flex use xl products the data did not show an increase over time (24 months).There is not a trend identified for the subclass too hot for flex use products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defect recorded for the batch.There was one wrap attribute defect recorded for a dead cell (individual cell not dosed with brine will not heat up).A brine pump was replaced to correct the dead cell.The individual dead cell did not affect the overall wrap average temperature causing it to be outside of the wrap average temperature specification.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degrees c - 41.6 degrees c).The shiftly production transition notes were reviewed.Other than the incident with a dead cell found during in process wrap attribute testing, there were no other incidents noted during manufacturing in the heat pack mak.
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Event Description
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Event verbatim [preferred term] after 90 minutes of running the patient had burns over the whole area of the wrap, with numerous blisters [burns second degree] , had noticed that the wrap was very hot, and that it was burning unpleasantly [device issue] , did not read the usage instructions before did not check the skin under it, engaged in exercise while using the product [device use error] , sweating [hyperhidrosis] ,.Case narrative:this is a spontaneous report from a pfizer sponsored program brand websites for division consumer healthcare austria from a contactable consumer reported for herself.A 42-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number r08719, expiration date jun2019, from 06feb2019 at 16:30 to 06feb2019 at 18:00 for 1.5 hours for tension in shoulder girdle, causing problems at running.The patient medical history included ongoing rather sensitive skin.The patient was currently not under the care of a physician for any medical condition, not pregnant and was not taking any medication during the time the problem was experienced.The patient has very light or fair skin tone and rather sensitive skin, but no abnormal skin conditions.There were no concomitant medications.The patient had previously already used thermacare heatwraps and other heat products for pain relief (latter 1-2 years ago) and had not previously experienced a problem/symptom with thermacare or any other of these products.The patient used thermacare heat wrap, purchased in red box, lot number r08719, expiration date jun2019.The patient had used a thermacare heat wrap 12 days ago (on 06feb2019), because she had tension in shoulder girdle, which hampered her during running.As she had used thermacare already several times in the last years, she knew that she tolerated the heat wraps well.But not this time.She did not know, whether the combination of thermacare with wet skin or saltiness on the skin, lead to the burns on 06feb2019 18:00.The fact was that after 90 minutes of running she had burns over the whole area of the heat wrap, which only now started to heal slowly.She sent a photo, that showed burns with numerous blisters 4 days after and reddening of the skin.She did not know if such a problem existed in general.In her opinion, the risk potential in connection with sport should be better pointed out.While wearing thermacare, the patient attached the adhesive to body, was wearing several layers of clothing over the thermacare product (no belt, no direct pressure to the product) and engaged in exercise (running 1.5 hours).The patient did not check her skin under the product while wearing thermacare and did not read the usage instructions before she used the product.After about 20 minutes of running the feeling changed from "pleasantly warm" to "it burns quite unpleasantly", it was unpleasant burning, but no severe pain.The pain started probably together with starting of sweating.The patient stated as soon as she started to sweat, she had noticed that the wrap was very hot, and that it was burning unpleasantly.The unpleasant feeling remained the same, did not become stronger.As she was alone and outdoors, she could not put off the clothes and check.Based on the burning feeling, she assumed, that the affected area for sure would be red, but she did not suppose the burns, otherwise she would have reacted.She stated that it was like this, that during running one focused on other things.If she was sitting on a couch at home, she would probably be more aware of the pain.She assumed that the problems are in the combination of the heat wrap and sweat (warmth, salt, moisture).The patient reported burns with blisters, starting on the 06feb2019 18:00 (after sport exercise), blisters were healing currently, had not disappeared completely yet, were strongly seen about 7 days.The patient did not consult a healthcare professional for the problem/symptoms.On 12mar2019, the consumer reported, "attached i am sending an actual photograph.You can see two big areas, where scars could remain and additionally some spots.In total the skin is very red and not beautiful - what is not normal.Normally i have quite a beautiful skin.I was jogging, so i trained sports and therefore i sweat quite a lot.As soon as i returned home after 1.5 hours, i stopped sweating.In my opinion, there was a relationship between the sweating and the burn." the action taken in response to the events for thermacare heatwrap was stopped on 06feb2019 at 18:00.The treatment included desinfection, special honey adhesive pads, day 1-2 betadona, therafter bepanthen, now calendula ointment.The outcome of burns with blisters and had noticed that the wrap was very hot, and that it was burning unpleasantly was recovering.The outcome of sweating was resolved in 2019.The outcome of the other event was unknown.According to product quality complaint group on 22feb2019: batch r08719 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and shows no obvious defect.An evaluation of the complaint history confirms that this is the first complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The pcom search returned a total of five complaints for flex use xl products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of too hot.Based on this pcom search for the subclass of too hot for flex use xl products the data did not show an increase over time (24 months).There is not a trend identified for the subclass too hot for flex use products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defect recorded for the batch.There was one wrap attribute defect recorded for a dead cell (individual cell not dosed with brine will not heat up).A brine pump was replaced to correct the dead cell.The individual dead cell did not affect the overall wrap average temperature causing it to be outside of the wrap average temperature specification.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degrees c - 41.6 degrees c).The shiftly production transition notes were reviewed.Other than the incident with a dead cell found during in process wrap attribute testing, there were no other incidents noted during manufacturing in the heat pack making portion of the line that would affect wrap temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures being outside of the required in process temperature specifications.Investigation summary: after a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she was wearing the wrap "for 90-minutes during jogging session" and "had an uncomfortable burning sensation on the skin under the patch." the cause of the burning sensation is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device; following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.According to product quality complaint group on 20mar2019, a site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.The severity ranking can not be assigned for a "too hot" complaint.The review of production records show no issues with thermal results for the batch, there was not a product quality complaint mentioned in the intake information.The sample is not available for evaluation by the site, a device malfunction cannot be confirmed.Follow-up (22feb2019): new information received from product quality complaint group includes investigation results.Follow-up (12mar2019 and 20mar2019): new information from the same consumer includes: updated event outcome of sweating, added other details.In addition, new information received from product quality complaint group includes additional investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of burns second degree, device issue and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event hyperhidrosis is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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