|
|
| Device Problems
Nonstandard Device (1420); Improper or Incorrect Procedure or Method (2017)
|
| Patient Problem
Partial thickness (Second Degree) Burn (2694)
|
| Event Date 01/01/2019 |
|
Event Type
Injury
|
|
Event Description
|
|
Got a blister about that size of a dime on her right butt cheek/it was red and the skin was already without the first layer of skin, burnt [burns second degree], slept with them on/wear thermacare lower back on her skin/did not check her skin under the product while wearing thermacare/using thermacare that day for 8-9 hours [device use error], had been using it to treat the bursitis in her hip [device use issue].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) female patient (no pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), from (b)(6) 2019 or (b)(6) 2019 and ongoing at every other day, sleeping in them, will wear it during the day if she was in pain for pain in her hips and sometimes on her back/pain in her back and bursitis in her hip.Medical history included sensitive skin and post-menopausal.Concomitant medication included unspecified drug.The patient previously used thermacare heatwraps for unknown indication and experienced same problem/symptom: there was a blister.It was red and the skin was already without the first layer of skin, burnt.The patient previously also used other heat product microwave gel pack for pain relief and did not experience a problem/symptom.The patient originally called about the recall.She reported that a couple of months ago in (b)(6) 2019 or (b)(6) 2019 a blister developed after using a box of the lower back and hip heatwraps.She disposed of all the packaging.She did not have the lot number or expiration date from it.She had 16 boxes of the lower back and hip that were the same number as the product effected by the recall.The product was in the car.She could not confirm the lot numbers.She stated that she would check them herself and call back with that information.She also mentioned that the thermacare was part of the treatment plan for a condition that she had.She stated that she got a blister about that size of a dime on her right butt cheek where she sat.It had already burnt the first layer of skin off.This happened about 2-3 months ago in (b)(6) 2019 or (b)(6) 2019.She slept with them on in 2019.She clarified that she was using them every other day and would only wear them during the day if she was in pain.She would put the thermacare lower back and hip heatwrap on when she came home from work and wear it until she woke up the next morning.She had an accident at work and had been using it to treat the bursitis in her hip and pain in her back.Specialty was unknown for the prescribing physician.She was sent to him by her work because she got hurt at work.When she woke up the next morning there was a blister on the right butt cheek the size of a dime.It was red and the skin was already without the first layer of skin, burnt in 2019.She had been using thermacare that day for 8-9 hours in 2019.The blister lasted about 4 or 5 days.She did not consult a healthcare professional for the symptom.She used gel that was like a barrier on it to make it heal.She would also use different creams to help with the pain.She would also get cortisone shots.She did not have the ndc number, lot number, or expiration date of the cortisone shots as they were given in the md office.She was not currently under the care of a physician for any medical condition.She classified her skin tone as very light.She had sensitive skin.She did not have any abnormal skin conditions.She purchased red box and there was no product remaining.She was sleeping while wearing the product in 2019.She wore thermacare lower back on her skin, then her panties, then her pajamas.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare in 2019.She did not read the usage instructions on thermacare before she used the product because she had used them before.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event blister burnt was resolved in 2019 and the outcome of the other events was unknown.The patient considered that there was a reasonable possibility that the event dime sized blister to the right butt cheek was related to the device.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 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 device use issue is non-serious.The events are medically assessed as associated with the use of the device.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] got a blister about that size of a dime on her right butt cheek/it was red and the skin was already without the first layer of skin, burnt [burns second degree] , slept with them on/wear thermacare lower back on her skin/did not check her skin under the product while wearing thermacare/using thermacare that day for 8-9 hours [device use error] , had been using it to treat the bursitis in her hip [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 64-year-old female patient (no pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), from (b)(6) 2019 or (b)(6) 2019 and ongoing at every other day, sleeping in them, will wear it during the day if she was in pain for pain in her hips and sometimes on her back/pain in her back and bursitis in her hip.Medical history included sensitive skin and post-menopausal.Concomitant medication included unspecified drug.The patient previously used thermacare heatwraps for unknown indication and experienced same problem/symptom: there was a blister.It was red and the skin was already without the first layer of skin, burnt.The patient previously also used other heat product microwave gel pack for pain relief and did not experience a problem/symptom.The patient originally called about the recall.She reported that a couple of months ago in (b)(6) 2019 or (b)(6) 2019 a blister developed after using a box of the lower back and hip heatwraps.She disposed of all the packaging.She did not have the lot number or expiration date from it.She had 16 boxes of the lower back and hip that were the same number as the product effected by the recall.The product was in the car.She could not confirm the lot numbers.She stated that she would check them herself and call back with that information.She also mentioned that the thermacare was part of the treatment plan for a condition that she had.She stated that she got a blister about that size of a dime on her right butt cheek where she sat.It had already burnt the first layer of skin off.This happened about 2-3 months ago in (b)(6) 2019 or (b)(6) 2019.She slept with them on in 2019.She clarified that she was using them every other day and would only wear them during the day if she was in pain.She would put the thermacare lower back and hip heatwrap on when she came home from work and wear it until she woke up the next morning.She had an accident at work and had been using it to treat the bursitis in her hip and pain in her back.Specialty was unknown for the prescribing physician.She was sent to him by her work because she got hurt at work.When she woke up the next morning there was a blister on the right butt cheek the size of a dime.It was red and the skin was already without the first layer of skin, burnt in 2019.She had been using thermacare that day for 8-9 hours in 2019.The blister lasted about 4 or 5 days.She did not consult a healthcare professional for the symptom.She used gel that was like a barrier on it to make it heal.She would also use different creams to help with the pain.She would also get cortisone shots.She did not have the ndc number, lot number, or expiration date of the cortisone shots as they were given in the md office.She was not currently under the care of a physician for any medical condition.She classified her skin tone as very light.She had sensitive skin.She did not have any abnormal skin conditions.She purchased red box and there was no product remaining.She was sleeping while wearing the product in 2019.She wore thermacare lower back on her skin, then her panties, then her pajamas.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare in 2019.She did not read the usage instructions on thermacare before she used the product because she had used them before.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event blister burnt was resolved in 2019 and the outcome of the other events was unknown.The patient considered that there was a reasonable possibility that the event dime sized blister to the right butt cheek was related to the device.According to product quality complaint group,the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up ((b)(6) 2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the information provided, the events of burns second degree 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 device use issue 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., comment: based on the information provided, the events of burns second degree 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 device use issue 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.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Severity of harm.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] got a blister about that size of a dime on her right butt cheek/it was red and the skin was already without the first layer of skin, burnt [burns second degree] , slept with them on/wear thermacare lower back on her skin/did not check her skin under the product while wearing thermacare/using thermacare that day for 8-9 hours [device use error] , had been using it to treat the bursitis in her hip [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 64-years-old female patient (no pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), from (b)(6) 2019 or (b)(6) 2019 and ongoing at every other day, sleeping in them, will wear it during the day if she was in pain for pain in her hips and sometimes on her back/pain in her back and bursitis in her hip.Medical history included sensitive skin and post-menopausal.Concomitant medication included unspecified drug.The patient previously used thermacare heatwraps for unknown indication and experienced same problem/symptom: there was a blister.It was red and the skin was already without the first layer of skin, burnt.The patient previously also used other heat product microwave gel pack for pain relief and did not experience a problem/symptom.The patient originally called about the recall.She reported that a couple of months ago in (b)(6) 2019 or (b)(6) 2019 a blister developed after using a box of the lower back and hip heatwraps.She disposed of all the packaging.She did not have the lot number or expiration date from it.She had 16 boxes of the lower back and hip that were the same number as the product effected by the recall.The product was in the car.She could not confirm the lot numbers.She stated that she would check them herself and call back with that information.She also mentioned that the thermacare was part of the treatment plan for a condition that she had.She stated that she got a blister about that size of a dime on her right butt cheek where she sat.It had already burnt the first layer of skin off.This happened about 2-3 months ago in (b)(6) 2019 or (b)(6) 2019.She slept with them on in 2019.She clarified that she was using them every other day and would only wear them during the day if she was in pain.She would put the thermacare lower back and hip heatwrap on when she came home from work and wear it until she woke up the next morning.She had an accident at work and had been using it to treat the bursitis in her hip and pain in her back.Specialty was unknown for the prescribing physician.She was sent to him by her work because she got hurt at work.When she woke up the next morning there was a blister on the right butt cheek the size of a dime.It was red and the skin was already without the first layer of skin, burnt in 2019.She had been using thermacare that day for 8-9 hours in 2019.The blister lasted about 4 or 5 days.She did not consult a healthcare professional for the symptom.She used gel that was like a barrier on it to make it heal.She would also use different creams to help with the pain.She would also get cortisone shots.She did not have the ndc number, lot number, or expiration date of the cortisone shots as they were given in the md office.She was not currently under the care of a physician for any medical condition.She classified her skin tone as very light.She had sensitive skin.She did not have any abnormal skin conditions.She purchased red box and there was no product remaining.She was sleeping while wearing the product in 2019.She wore thermacare lower back on her skin, then her panties, then her pajamas.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare in 2019.She did not read the usage instructions on thermacare before she used the product because she had used them before.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event blister burnt was resolved in 2019 and the outcome of the other events was unknown.The patient considered that there was a reasonable possibility that the event dime sized blister to the right butt cheek was related to the device.According to product quality complaint group,the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Severity of harm: s3.Follow-up (b)(6) 2019: new information received from a product quality complaint group included: investigation results.Follow-up(b)(6) 2019: new information received from a product quality complaint group included: severity level.Company clinical evaluation comment: based on the information provided, the events of burns second degree 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 device use issue 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., comment: based on the information provided, the events of burns second degree 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 device use issue 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.
|
| |
|
Manufacturer Narrative
|
|
The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Severity of harm was s3.Investigation results dated 04feb2020 were as follows: exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: (b)(6)2016 through (b)(6)2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor.The citi customizable search returned a total of 697 complaints for lower back/hip (lbh) 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 adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclass shows an increase in november 2016 through april 2017, november 2017 through april 2018 and november 2018 through apr2019.This is a seasonality change in combination with a change in safety's procedure that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline and an overall increase.
|
| |
|
Event Description
|
|
Event verbatim [preferred term]: got a blister about that size of a dime on her right butt cheek/it was red and the skin was already without the first layer of skin, burnt [burns second degree], slept with them on/wear thermacare lower back on her skin/did not check her skin under the product while wearing thermacare/using thermacare that day for 8-9 hours [device use error] , had been using it to treat the bursitis in her hip [device use issue].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 64-years-old female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), from (b)(6)2019 and ongoing at every other day, sleeping in them, will wear it during the day if she was in pain for pain in her hips and sometimes on her back/pain in her back and bursitis in her hip.Medical history included sensitive skin and post-menopausal.Concomitant medication included unspecified drug.The patient previously used thermacare heatwraps for unknown indication and experienced same problem/symptom: there was a blister.It was red and the skin was already without the first layer of skin, burnt.The patient previously also used other heat product microwave gel pack for pain relief and did not experience a problem/symptom.The patient originally called about the recall.She reported that a couple of months ago in (b)(6) 2019 a blister developed after using a box of the lower back and hip heatwraps.She disposed of all the packaging.She did not have the lot number or expiration date from it.She had 16 boxes of the lower back and hip that were the same number as the product effected by the recall.The product was in the car.She could not confirm the lot numbers.She stated that she would check them herself and call back with that information.She also mentioned that the thermacare was part of the treatment plan for a condition that she had.She stated that she got a blister about that size of a dime on her right butt cheek where she sat.It had already burnt the first layer of skin off.This happened about 2-3 months ago in (b)(6)2019.She slept with them on in 2019.She clarified that she was using them every other day and would only wear them during the day if she was in pain.She would put the thermacare lower back and hip heatwrap on when she came home from work and wear it until she woke up the next morning.She had an accident at work and had been using it to treat the bursitis in her hip and pain in her back.Specialty was unknown for the prescribing physician.She was sent to him by her work because she got hurt at work.When she woke up the next morning there was a blister on the right butt cheek the size of a dime.It was red and the skin was already without the first layer of skin, burnt in 2019.She had been using thermacare that day for 8-9 hours in 2019.The blister lasted about 4 or 5 days.She did not consult a healthcare professional for the symptom.She used gel that was like a barrier on it to make it heal.She would also use different creams to help with the pain.She would also get cortisone shots.She did not have the ndc number, lot number, or expiration date of the cortisone shots as they were given in the md office.She was not currently under the care of a physician for any medical condition.She classified her skin tone as very light.She had sensitive skin.She did not have any abnormal skin conditions.She purchased red box and there was no product remaining.She was sleeping while wearing the product in 2019.She wore thermacare lower back on her skin, then her panties, then her pajamas.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare in 2019.She did not read the usage instructions on thermacare before she used the product because she had used them before.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event blister burnt was resolved in 2019 and the outcome of the other events was unknown.The patient considered that there was a reasonable possibility that the event dime sized blister to the right butt cheek was related to the device.According to product quality complaint group, the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Severity of harm was s3.Investigation results dated (b)(6) 2020 were as follows: exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: (b)(6) 2016 through (b)(6)2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor.The citi customizable search returned a total of 697 complaints for lower back/hip (lbh) 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 adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclass shows an increase in november 2016 through april 2017, november 2017 through april 2018 and november 2018 through apr2019.This is a seasonality change in combination with a change in safety's procedure that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline and an overall increase of subsequent complaints received at the site.Six of the 8 complaint received in august 2016 were related to burns, blisters and irritation.Ten of the 13 complaints received september 2016 were related to burns, blisters and redness.Seven of the 8 complaints received in october 2016 were related to burns, rash and blisters.Eleven of the 16 complaints received in may of 2017 were related to burns, rash and blisters.Seven of the 9 complaints received in sep2017 were related burns, blister and redness.Seven of the 9 complaints received in may 2018 were related to burn and blisters.Six of the 8 complaints received in july 2018 were related to burns, rash and blisters.Twelve of the 16 complaints received in oct2018 were related to burns, blisters, redness and wrap too hot.The data shows a spike of complaints received in may 2019.Eighty seven of the 184 complaints received were related to burns, blisters, and redness; forty has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.April through may of 2019 shows an increase attributed to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor for lbh 8hr products, unknown lbh adverse event/serious/unknown 23may2016 to 23may2019.No further action is required.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Return sample evaluation: a return sample has not been received at the site for evaluation as of 28jan2020.Follow-up (13jun2019): new information received from a product quality complaint group included: investigation results.Follow-up(27aug2019): new information received from a product quality complaint group included: severity level.Follow-up (29sep2019): follow-up attempts are completed.No further information is expected.Follow-up (04feb2020): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the information provided, the events of burns second degree 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 device use issue 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.Comment: based on the information provided, the events of burns second degree 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 device use issue 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.
|
| |
|
Search Alerts/Recalls
|
|
|
