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| Device Problem
Overheating of Device (1437)
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| Patient Problems
Skin Irritation (2076); Rupture (2208); Burn, Thermal (2530)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] hot spots that became blisters [thermal burn] , hot spots that became blisters [blister] , if the blister broke, she used antibiotic ointment and tried not to rub it [blister rupture] , she could get red spots with sore and irritation leading up to blistering [skin irritation] , wearing a belt created more problems, meaning she got hot spots more often/was wearing several layers of clothing over the product/did not check the skin [intentional device misuse] , lower back wrap wrinkles up [product physical issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A caucasian female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip), from an unspecified date to an unspecified date at an unspecified dose for lower back pain.The patient medical history was not reported.Concomitant medication included mestranol, norethisterone (ortho novum) birth control pills, 3 weeks on, 1 week off, ibuprofen (ibuprofen) 800 mg nightly as needed for back pain and 400 mg daily as needed for back pain.The patient reported when using the lower back and hip wraps in the past, the product wrinkled up and she developed hot spots that became blisters if she did not move the heat cell.She could get red spots with sore and irritation leading up to blistering.The events took place ages and ages ago.It could have been as long ago as the 1990s.The last known date of blisters is unknown.The blisters were on the surface.She did not see an hcp for these events but treated them with a band aid.If the blister broke, she used antibiotic ointment and tried not to rub it.They were not second or third degree burns, just blisters on the lower back, at or below the waist, where the wrap was.This happened a couple of times.It depended on what she was wearing.Wearing a belt created more problems, meaning she got hot spots more often.She could get red spots with sore and irritation leading up to blistering.Hot spots began around the late 1990s or around 2000.She permanently stopped using the lower back and hip wraps in the 2000s when the menstrual wraps came out on the market.The product was not available; the product was discarded by the patient.The outcome of the events was resolved on an unspecified date.She classified her skin tone as medium with no skin sensitivity.She does not have any abnormal skin conditions.The product was used for one day in a row for 8 hours.The patient used the product on and off since it came to market.The patient did not previously use other heat products.The patient did not sleep while wearing the product.She was wearing several layers of clothing over the product.She was wearing a snug waistband/belt that applied pressure over the area.She did not engage in exercise while wearing the product.She did not check the skin while wearing the product.She did read the instructions before use.No follow-up attempts are possible.An investigation of the device could not be conducted.Company clinical evaluation comment based on the information provided, the reported events thermal burn, blister, blister rupture, skin irritation, intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event product physical issue is assessed as associated with the device.Comment: based on the information provided, the reported events thermal burn, blister, blister rupture, skin irritation, intentional device misuse as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other event product physical issue is assessed as associated with the device.
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Event Description
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Event verbatim [preferred term] hot spots that became blisters/if the blister broke/she could get red spots with sore and irritation leading up to blistering [burns second degree] , wearing a belt created more problems/was wearing several layers of clothing over the product/wearing a snug waistband/belt that applied pressure over the area/did not check the skin [intentional device misuse] , lower back wrap wrinkles up [device issue].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for lower back pain.The patient medical history was not reported.Concomitant medication included mestranol, norethisterone (ortho novum) birth control pills, 135-3 weeks on, 1 week off, ibuprofen from an unspecified date to an unspecified date at 800 mg nightly as needed and from an unspecified date at 400 mg daily as needed for back pain.The patient reported when using the lower back and hip wraps in the past, the product wrinkled up and she developed hot spots that became blisters if she did not move the heat cell.She could get red spots with sore and irritation leading up to blistering.The events took place ages and ages ago.It could have been as long ago as the 90s.The last known date of blisters was unknown.The blisters were on the surface.She did not see a healthcare professional for these events but treated them with a band aid.If the blister broke, she used antibiotic ointment and tried not to rub it.They were not second or third degree burns, just blisters on the lower back, at or below the waist, where the wrap was.This happened a couple of times.It depended on what she was wearing.Wearing a belt created more problems, meaning she got hot spots more often.Hot spots began around the late 1990s or around 2000.The product was not available; the product was discarded by the patient.She classified her skin tone as medium with no skin sensitivity.She did not have any abnormal skin conditions.The product was used for one day in a row for 8 hours.The patient used the product on and off since it came to market.The patient did not previously use other heat products.The patient did not sleep while wearing the product.She was wearing several layers of clothing over the product.She was wearing a snug waistband/belt that applied pressure over the area.She did not engage in exercise while wearing the product.She did not check the skin while wearing the product.She did read the instructions before use.She permanently stopped using the lower back and hip wraps in the 2000s when the menstrual wraps came out on the market.The outcome of the event "wearing a belt created more problems/was wearing several layers of clothing over the product/wearing a snug waistband/belt that applied pressure over the area/did not check the skin" was unknown.The outcome of other events was resolved on an unspecified date.Amendment: this follow-up report is being submitted to amend previously reported information: updated events outcome in the narrative.The event "lower back wrap wrinkles up" was serious due to intervention required.Events coding updated (subsume "hot spots that became blisters/if the blister broke/she could get red spots with sore and irritation leading up to blistering" into one event and coded as burn blister).Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the reported events burn blister, intentional device misuse and device issue as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure and assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] hot spots that became blisters/if the blister broke/she could get red spots with sore and irritation leading up to blistering [burns second degree], wearing a belt created more problems/was wearing several layers of clothing over the product/wearing a snug waistband/belt that applied pressure over the area/did not check the skin [intentional device misuse], lower back wrap wrinkles up [device issue].Case narrative:this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for lower back pain.The patient medical history was not reported.Concomitant medication included mestranol, norethisterone (ortho novum) birth control pills, 135-3 weeks on, 1 week off, ibuprofen from an unspecified date to an unspecified date at 800 mg nightly as needed and from an unspecified date at 400 mg daily as needed for back pain.The patient reported when using the lower back and hip wraps in the past, the product wrinkled up and she developed hot spots that became blisters if she did not move the heat cell.She could get red spots with sore and irritation leading up to blistering.The events took place ages and ages ago.It could have been as long ago as the 90s.The last known date of blisters was unknown.The blisters were on the surface.She did not see a healthcare professional for these events but treated them with a band aid.If the blister broke, she used antibiotic ointment and tried not to rub it.They were not second or third degree burns, just blisters on the lower back, at or below the waist, where the wrap was.This happened a couple of times.It depended on what she was wearing.Wearing a belt created more problems, meaning she got hot spots more often.Hot spots began around the late 1990s or around 2000.The product was not available; the product was discarded by the patient.She classified her skin tone as medium with no skin sensitivity.She did not have any abnormal skin conditions.The product was used for one day in a row for 8 hours.The patient used the product on and off since it came to market.The patient did not previously use other heat products.The patient did not sleep while wearing the product.She was wearing several layers of clothing over the product.She was wearing a snug waistband/belt that applied pressure over the area.She did not engage in exercise while wearing the product.She did not check the skin while wearing the product.She did read the instructions before use.She permanently stopped using the lower back and hip wraps in the 2000s when the menstrual wraps came out on the market.The outcome of the event "wearing a belt created more problems/was wearing several layers of clothing over the product/wearing a snug waistband/belt that applied pressure over the area/did not check the skin" was unknown.The outcome of other events was resolved on an unspecified date.Product investigation results were as follows: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage and investigation (citi) search was performed.Scope: date contacted: 07oct2013 through 07oct2016/ manufacturing site: pfizer (site name) /complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The citi search returned a total 230 complaints for the lower back and hip (lbh) products during this time period for the class/subclass adverse event safety request for investigation.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows a seasonality increase in (b)(6) 2015, (b)(6) 2015, (b)(6) 2016, (b)(6) 2016, and (b)(6) 2016.A change in safety's procedure 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.The data shows an increase of 17 complaints received in mar2015; fourteen of the 17 were related to burns, blisters, and redness.Twelve of the 17 complaints received in (b)(6) 2015 were related to burns, redness and blisters.Based on this citi search, there is not a trend identified for the subclass of adverse event safety request for investigation.There is no further action 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 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.Reasonably suggest device malfunction: no.A return sample has not been received at the site for evaluation as of (b)(6) 2020.Amendment: this follow-up report is being submitted to amend previously reported information: updated events outcome in the narrative.The event "lower back wrap wrinkles up" was serious due to intervention required.Events coding updated (subsume "hot spots that became blisters/if the blister broke/she could get red spots with sore and irritation leading up to blistering" into one event and coded as burn blister).Follow-up (03apr2020): new information received from a product quality complaint group includes product investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the reported events burn blister, intentional device misuse and device issue as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure and assessed as associated with the use of the device.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.No further investigations or actions are suggested at this time.
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Manufacturer Narrative
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An evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage and investigation (citi) search was performed.Scope: date contacted: (b)(6) 2013 through (b)(6) 2016/ manufacturing site: pfizer (site name) /complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The citi search returned a total 230 complaints for the lower back and hip (lbh) products during this time period for the class/subclass adverse event safety request for investigation.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows a seasonality increase in (b)(6) 2015, (b)(6) 2015, (b)(6) 2016, (b)(6) 2016, and (b)(6) 2016.A change in safety¿s procedure 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.The data shows an increase of 17 complaints received in (b)(6) 2015; fourteen of the 17 were related to burns, blisters, and redness.Twelve of the 17 complaints received in (b)(6) 2015 were related to burns, redness and blisters.Based on this citi search, there is not a trend identified for the subclass of adverse event safety request for investigation.There is no further action 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 safety request for investigation.The manufacturing operations employ quality control procedures which include.
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Search Alerts/Recalls
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