|
|
| Lot Number N15776 |
| Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
|
| Patient Problems
Nerve Damage (1979); Tissue Damage (2104); Burn, Thermal (2530)
|
| Event Date 11/19/2016 |
|
Event Type
Injury
|
|
Event Description
|
|
Event verbatim.Burned everywhere almost down to her buttcrack [thermal burn], pulled some of her skin off when she pulled the heatwrap off [skin exfoliation], fell asleep and had it on for about 9 hours, did not check skin under wrap during use [intentional device misuse], fell asleep and had it on for about 9 hours, did not check skin under wrap during use [device use error].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip)(device lot number: n15776, expiration date: mar2019) from (b)(6) 2016 for back injury.Medical history included pain from an unknown date and unknown if ongoing (taking oxycodone and oxycontin), nerve damage (taking neurontin) from an unknown date and unknown if ongoing and neuropathy peripheral from an unknown date and unknown if ongoing.Concomitant medication included oxycodone (oxycodone), oxycodone hydrochloride (oxycontin) and gabapentin (neurontin).Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient stated that she put a heatwrap on her back and everything was fine.On (b)(6) 2016, the patient applied a heatwrap directly to her back and it was kind of late in the day and fell asleep and had it on for about 9 hours.When the patient woke up on (b)(6) 2016, she had the thermacell marks on her entire back and was burned everywhere almost down to her buttcrack.She mentioned the heatwrap got hot, but it did not feel like it got hot enough to the point of burning her.She stated the shape of the burns are the shape of the heat cells.The patient fell asleep in almost a sitting up position and had pillows behind her.She mentioned she knows you are not supposed to have it on for more than 8 hours.The patient reported the heatwrap pulled some of her skin off when she pulled the heatwrap off.The patient assessed her skin tone as very light or fair.She is currently seeing a physician for her back injury.The patient denied having sensitive skin or abnormal skin conditions.She is not pregnant and not post-menopausal.The patient previously used a heating pad for pain relief for 3-4 hours at a time with no adverse effect.She did not engage in exercise while wearing the wrap and did not check her skin under the wrap during use.The patient read the usage instructions on the heatwrap prior to usage.Action taken with the suspect product was permanently discontinued on (b)(6) 2016.Therapeutic measures included neosporin on the burns because she doesn't want to get a secondary infection.Clinical outcome of the events was not resolved.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 burned and pulled some of her skin off, after falling asleep with heatwrap for about 9 hours/did not check skin under wrap during use are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.Comment: based on the information provided, the events of burned, pulled some of her skin off after falling asleep with heatwrap for about 9 hours/did not check skin under wrap during use are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.
|
| |
|
Manufacturer Narrative
|
|
Investigation summary: the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in process sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burned everywhere almost down to her buttcrack [thermal burn] , pulled some of her skin off when she pulled the heatwrap off [skin exfoliation] , got blisters on her back/ it blistered her/it left her back hurting and got blisters [blister] , fell asleep and had it on for about 9 hours, did not check skin under wrap during use [intentional device misuse] , fell asleep and had it on for about 9 hours, did not check skin under wrap during use [device use error] , fell asleep and had it on for about 9 hours [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n15776, expiration date: mar2019) from (b)(6) 2016 for back injury.Medical history included pain from an unknown date and unknown if ongoing (taking oxycodone and oxycontin), nerve damage (taking neurontin) from an unknown date and unknown if ongoing, and neuropathy peripheral from an unknown date and unknown if ongoing.Concomitant medications included oxycodone for pain, oxycodone hydrochloride (oxycontin) for pain, and gabapentin (neurontin) for nerve damage.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient stated that she put a heatwrap on her back and everything was fine.On (b)(6) 2016, the patient applied a heatwrap directly to her back and it was kind of late in the day and fell asleep and had it on for about 9 hours.When the patient woke up on (b)(6) 2016, she had the thermacell marks on her entire back and was burned everywhere almost down to her buttcrack.She mentioned the heatwrap got hot, but it did not feel like it got hot enough to the point of burning her.She stated the shape of the burns were the shape of the heat cells.The patient fell asleep in almost a sitting up position and had pillows behind her.She mentioned she knows you are not supposed to have it on for more than 8 hours.The patient reported the heatwrap pulled some of her skin off when she pulled the heatwrap off.The patient also mentioned that she used one of the pfizer's thermacare heatwrap for back pain therapy and she just took it off and it burned her skin.She added she has got blisters on her back.Consumer further added that it blistered her.Consumer said she just took it off.She added she put it on the day until afternoon and then she just took it off and it left her back hurting and got blisters.The patient assessed her skin tone as very light or fair.She was currently seeing a physician for her back injury.The patient denied having sensitive skin or abnormal skin conditions.She was not pregnant and not post-menopausal.The patient previously used a heating pad for pain relief for 3-4 hours at a time with no adverse effect.She did not engage in exercise while wearing the wrap and did not check her skin under the wrap during use.The patient read the usage instructions on the heatwrap prior to usage.Action taken with the suspect product was permanently discontinued on (b)(6) 2016.Therapeutic measures included neosporin on the burns and pulled some of her skin off when she pulled the heatwrap off because she doesn't want to get a secondary infection.The outcome of the events "burned everywhere almost down to her buttcrack" and "pulled some of her skin off when she pulled the heatwrap off" was not resolved.The outcome of the other events was unknown.According to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in process sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (05jan2017): new information received from product quality complaint group includes investigation results.In addition, added new event "got blisters on her back/ it blistered her/it left her back hurting and got blisters".Company clinical evaluation comment based on the information provided, the reported events thermal burn, skin loss, blister, intentional device misuse, wrong technique in device usage process, and intentional device use issue 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.No device malfunction has been identified.Comment: based on the information provided, the reported events thermal burn, skin loss, blister, intentional device misuse, wrong technique in device usage process, and intentional device use issue 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.No device malfunction has been identified.
|
| |
|
Manufacturer Narrative
|
|
Investigation summary: the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in process sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burned everywhere almost down to her buttcrack [thermal burn] , pulled some of her skin off when she pulled the heatwrap off [skin exfoliation], got blisters on her back/ it blistered her/it left her back hurting and got blisters [blister] , fell asleep and had it on for about 9 hours, did not check skin under wrap during use [intentional device misuse], fell asleep and had it on for about 9 hours, did not check skin under wrap during use [device use error], fell asleep and had it on for about 9 hours [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n15776, expiration date: mar2019) from (b)(6) 2016 for back injury.Medical history included pain from an unknown date and unknown if ongoing (taking oxycodone and oxycontin), nerve damage (taking neurontin) from an unknown date and unknown if ongoing, and neuropathy from an unknown date and unknown if ongoing.Concomitant medications included oxycodone at 15 mg, as needed and also reported as 15mg up to 5 pills a day oral as needed for pain from (b)(6) 2014, oxycodone hydrochloride (oxycontin) at 40 mg, 3x/day oral from (b)(6) 2014 for pain, and gabapentin (neurontin) at 800 mg, 3x/day oral from (b)(6) 2014 for nerve damage.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient stated that she put a heatwrap on her back and everything was fine.On (b)(6) 2016, the patient applied a heatwrap directly to her back and it was kind of late in the day and fell asleep and had it on for about 9 hours.When the patient woke up on (b)(6) 2016, she had the thermacell marks on her entire back and was burned everywhere almost down to her buttcrack.She mentioned the heatwrap got hot, but it did not feel like it got hot enough to the point of burning her.She stated the shape of the burns were the shape of the heat cells.The patient fell asleep in almost a sitting up position and had pillows behind her.She mentioned she knew you were not supposed to have it on for more than 8 hours.The patient reported the heatwrap pulled some of her skin off when she pulled the heatwrap off.The patient also mentioned that she used one of the pfizer's thermacare heatwrap for back pain therapy and she just took it off and it burned her skin.She added she had got blisters on her back.Consumer further added that it blistered her.Consumer said she just took it off.She added she put it on the day until afternoon and then she just took it off and it left her back hurting and got blisters.The patient assessed her skin tone as very light or fair.She was currently seeing a physician for her back injury.The patient denied having sensitive skin or abnormal skin conditions.She was not pregnant and not post-menopausal.The patient previously used a heating pad for pain relief for 3-4 hours at a time with no adverse effect.She did not engage in exercise while wearing the wrap and did not check her skin under the wrap during use.The patient read the usage instructions on the heatwrap prior to usage.Action taken with the suspect product was permanently discontinued on (b)(6) 2016.Therapeutic measures included neosporin on the burns and pulled some of her skin off when she pulled the heatwrap off because she didn't want to get a secondary infection.The outcome of the events "burned everywhere almost down to her buttcrack" and "pulled some of her skin off when she pulled the heatwrap off" was not resolved.The outcome of the other events was unknown.The physician reported the patient did not provide information regarding the reported events.According to the product quality complaint group: investigation summary: the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in process sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (05jan2017): new information received from product quality complaint group includes investigation results.In addition, added new event "got blisters on her back/ it blistered her/it left her back hurting and got blisters." follow-up (14feb2017): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.Case updated with device evaluated by manufacturer field from blank to not returned to manufacturer and evaluation codes of 75 updated to 71.Company clinical evaluation comment: based on the information provided, the reported events thermal burn, skin loss, blister, intentional device misuse, wrong technique in device usage process, and intentional device use issue 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.No device malfunction has been identified.Comment: based on the information provided, the reported events thermal burn, skin loss, blister, intentional device misuse, wrong technique in device usage process, and intentional device use issue 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.No device malfunction has been identified.
|
| |
|
Search Alerts/Recalls
|
|
|
