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PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT
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| Lot Number N97804 |
| Device Problem
Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Erythema (1840); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Itching Sensation (1943); Pain (1994); Rash (2033); Swelling (2091); Discomfort (2330); Burn, Thermal (2530)
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| Event Date 10/01/2016 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] burn/stinging/pain [thermal burn]; inflammation [inflammation]; did not check skin under heatwrap during use, used the wrap directly against her skin [device use error]; itching [pruritus]; was all broken out on various parts of her body, rash was all over her skin [rash]; scratches [scratch]; not helping in her pain [device ineffective]; using for fibromyalgia [device use issue]; my back is killing me/ back discomfort [back disorder]; shoulder discomfort [musculoskeletal discomfort]; swelling [swelling]; the areas underneath both wraps were red, inflamed, burned, and had rashes [erythema]; when she saw her rheumatologist he took her blood pressure and it was a little elevated [blood pressure increased].Case narrative:this is a spontaneous report from a (b)(4).A contactable consumer reported that a (b)(6) (b)(6) female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot number: n97804, expiration date: apr2019) from (b)(6) 2016 for fibromyalgia, back pain and one wrap to shoulder for shoulder pain.Medical history included ongoing arthritis, pain (diagnosed with both probably over 6 years ago), ongoing osteoarthritis (in hands, 5 years, maybe less), ongoing fibromyalgia, ongoing chronic pain syndrome, post-menopausal was reported as no, she was still experiencing menopause, and sensitive skin.Concomitant medications included hydrocodone bitartrate, paracetamol (norco) 10-325mg tablet one every 4 to 6 hours for pain, and cyclobenzaprine, 10mg tablet at bedtime for pain.On 07oct2016, the patient reported she applied the heatwrap directly to her skin for probably 3 or 4 hours and she kept breaking out and it was not helping in her pain.She stated she was all broken out on various parts of her body from where she had used the heatwrap with scratches she got from the itching and rash.The patient was hospitalized on an unspecified date in 2016 as a result of the events scratches, itching and rash.Upon received follow-up (20jan2017), the reporter further reported "my back is killing me".She also reported after using the product she had rashes, was severely burned and had shoulder and back discomfort.The patient experienced rash, burn, itching, swelling, inflammation in (b)(6) 2016.The patient experienced shoulder discomfort, back discomfort from an unspecified date.The consumer stated that around (b)(6) 2016 she applied a thermacare advanced joint pain therapy heat wrap to her shoulder and a thermacare back pain therapy heat wrap to her lower back.She had them in place for two to three hours, but then at work she started getting a stinging, burning feeling so went to remove the wraps and noticed that the areas underneath both wraps were red, inflamed, burned, and had rashes.The burn on her shoulder was worse than on her lower back.She applied aloe vera and that soothed the burning.She went and saw her rheumatologist and he prescribed her a prednisone taper.She took four 10mg tablets for 3 days then three 10mg tablets for 3 days, then two 10mg tablets for 3 days, then one 10mg tablet for 3 days then stopped.It took a few days, but eventually the redness and inflammation went away.She still had marks where the burn and rashes were, but they were not burned or itching anymore.When she saw her rheumatologist he took her blood pressure and it was a little elevated because of the pain she was experiencing.The shoulder and back discomfort had been getting better, but for some reason last week it got really bad again.She just used a regular heating pad over her clothes, but that did not work.It has since gone back to feeling better.The consumer had tried using aspercreme and capsaicin cream for shoulder and back discomfort in the past, but neither did anything for her.The patient reported there were no defects in the wrap like cuts, tears, leaks or holes.She did not change or modify the wrap in any way.The patient did not put the wrap in the microwave and did not use the wrap overnight or while sleeping.She used the wrap over healthy skin and over the correct part of the body.The patient did not overlap the wrap and did not apply any pressure over the wrap.She did not wear more than 2 layers of clothing over the wrap and did not sit or recline for a prolonged period of time while using the wrap.The patient did not exercise while using the wrap and did not use more than one heatwrap per day.Her skin tone was dark.No abnormal skin conditions.She did not think she had used it before.If she had, she did not have this reaction.She previously uses an electric heating pad over her clothes shoulder and/or lower back pain as soon as she started sweating she would stop using it.She was wearing undergarments and clothing over the thermacare product.She did read the usage instructions on thermacare before she used the product.When the patient was asked how often did she check under the wrap, she answered did not check it.When the patient was asked did she check her skin under the product while wearing thermacare, she answered she started experiencing stinging and burning after wearing them for 2 to 3 hours.Action taken with the suspect product was permanently withdrawn on an unspecified date.The outcome of the events burn/stinging/pain, itching, rash, scratches, shoulder discomfort was resolving.The outcome of swelling inflammation, redness was resolved on an unspecified date.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow up (08oct2016 and 10oct2016): new information received from product quality complaint includes: additional product lot number, reaction data (reported event terms of "fibromyalgia/did not check skin under heatwrap during use" were split and coded separately).Follow-up (17nov2016): new information received from a contactable consumer includes: updated suspect product start date and lot number, action taken with the suspect product and patient hospitalization required.Follow-up (20jan2017): new information received from a (b)(4) includes: added concomitant medications; new events burn/stinging/pain, inflammation, "my back is killing me/ back discomfort", shoulder discomfort, swelling, stinging/pain, redness, blood pressure a little elevated.Company clinical evaluation comment: based on the information provided, the reported events thermal burn, inflammation, and device use error are 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 events are assessed as associated with device use., comment: based on the information provided, the reported events thermal burn, inflammation, and device use error are 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 events are assessed as associated with device use.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).The cause of the alleged lack of effect defect is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.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.
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Event Description
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Event verbatim [preferred term] itching [pruritus] , was all broken out on various parts of her body, rash was all over her skin [rash] , burn/stinging/pain [thermal burn] , inflammation [inflammation] , did not check skin under heatwrap during use, used the wrap directly against her skin [device use error] , scratches [scratch] , not helping in her pain [device ineffective] , using for fibromyalgia [device use issue] , my back is killing me/ back discomfort [back disorder] , shoulder discomfort [musculoskeletal discomfort] , swelling [swelling] , the areas underneath both wraps were red, inflamed, burned, and had rashes [erythema] , when she saw her rheumatologist he took her blood pressure and it was a little elevated [blood pressure increased] ,.Case narrative: this is a spontaneous report from a pfizer-sponsored program (pfizer product refund program).A contactable consumer reported that a (b)(6)-year-old black (african american) female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot number: n97804, expiration date: apr2019) from (b)(6) 2016 for fibromyalgia, back pain and one wrap to shoulder for shoulder pain.Medical history included ongoing arthritis, pain (diagnosed with both probably over 6 years ago), ongoing osteoarthritis (in hands, 5 years, maybe less), ongoing fibromyalgia, ongoing chronic pain syndrome, post-menopausal was reported as no, she was still experiencing menopause, and sensitive skin.Concomitant medications included hydrocodone bitartrate, paracetamol (norco) 10-325mg tablet one every 4 to 6 hours for pain, and cyclobenzaprine, 10mg tablet at bedtime for pain.On (b)(6) 2016, the patient reported she applied the heatwrap directly to her skin for probably 3 or 4 hours and she kept breaking out and it was not helping in her pain.She stated she was all broken out on various parts of her body from where she had used the heatwrap with scratches she got from the itching and rash.The patient was hospitalized on an unspecified date in 2016 as a result of the events scratches, itching and rash.Upon received follow-up ((b)(6)), the reporter further reported "my back is killing me".She also reported after using the product she had rashes, was severely burned and had shoulder and back discomfort.The patient experienced rash, burn, itching, swelling, inflammation on an unspecified date in (b)(6) 2016.She experienced shoulder discomfort, back discomfort on an unspecified date.The patient stated that around (b)(6) 2016 or (b)(6) 2016 she applied a thermacare advanced joint pain therapy heatwrap to her shoulder and a thermacare back pain therapy heatwrap to her lower back.She had them in place for two to three hours, but then at work she started getting a stinging, burning feeling so went to remove the wraps and noticed that the areas underneath both wraps were red, inflamed, burned, and had rashes.The burn on her shoulder was worse than on her lower back.She applied aloe vera and that soothed the burning.The patient saw her rheumatologist and he prescribed a prednisone taper.She took four 10mg tablets for 3 days then three 10mg tablets for 3 days, then two 10mg tablets for 3 days, then one 10mg tablet for 3 days then stopped.It took a few days, but eventually the redness and inflammation went away.She still had marks where the burn and rashes were, but they were not burning or itching anymore.When she saw her rheumatologist he took her blood pressure and it was a little elevated because of the pain she was experiencing.The shoulder and back discomfort had been getting better, but for some reason last week it got really bad again.She just used a regular heating pad over her clothes, but that did not work.It has since gone back to feeling better.The patient had tried using aspercreme and capsaicin cream for shoulder and back discomfort in the past, but neither did anything for her.The patient assessed her skin tone as dark.She reported there were no defects in the wrap like cuts, tears, leaks or holes.The patient did not change or modify the wrap in any way.She did not put the wrap in the microwave and did not use the wrap overnight or while sleeping.The patient used the wrap over healthy skin and over the correct part of the body.She did not overlap the wrap and did not apply any pressure over the wrap.The patient did not wear more than 2 layers of clothing over the wrap and did not sit or recline for a prolonged period of time while using the wrap.She did not exercise while using the wrap and did not use more than one heatwrap per day.No abnormal skin conditions were reported.She did not think she had used it before.If she had, she did not have this reaction.She previously used an electric heating pad over her clothes shoulder and/or lower back pain as soon as she started sweating she would stop using it.She was wearing undergarments and clothing over the thermacare product.She did read the usage instructions on thermacare before she used the product.When the patient was asked how often did she check under the wrap, she answered she did not check it.Action taken with the suspect product was permanently withdrawn on an unspecified date.The outcome of the events burn/stinging/pain, itching, rash, scratches, shoulder discomfort was resolving.The outcome of swelling inflammation, redness was resolved on an unspecified date.The outcome of other events was unknown.As of (b)(6) 2017, the product quality complaint (pqc) group investigation results stated that the root cause category is non-assignable (complaint not confirmed).The cause of the alleged lack of effect defect is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.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.Additional information has been requested and will be provided as it becomes available.Follow up ((b)(6) 2016 and (b)(6) 2016): new information received from product quality complaint includes: additional product lot number, reaction data (reported event terms of "fibromyalgia/did not check skin under heatwrap during use" were split and coded separately).Follow-up ((b)(6) 2016): new information received from a contactable consumer includes: updated suspect product start date and lot number, action taken with the suspect product and patient hospitalization required.Follow-up ((b)(6) 2017): new information received from a pfizer-sponsored program pfizer product refund program includes: added concomitant medications; new events burn/stinging/pain, inflammation, "my back is killing me/ back discomfort", shoulder discomfort, swelling, stinging/pain, redness, blood pressure a little elevated.Follow-up ((b)(6) 2017): new information reported from the pqc group includes: product investigation summary results.Company clinical evaluation comment based on the information provided, the reported events thermal burn, inflammation, and device use error are 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 events are assessed as associated with device use., comment: based on the information provided, the reported events thermal burn, inflammation, and device use error are 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 events are assessed as associated with device use.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).The cause of the alleged lack of effect defect is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.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.
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Event Description
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Event verbatim [preferred term] did not check skin under heatwrap during use, used the wrap directly against her skin [device use error] , itching [pruritus] , was all broken out on various parts of her body, rash was all over her skin [rash] , scratches [scratch] , burn/stinging/pain [thermal burn] , inflammation [inflammation] , not helping in her pain [device ineffective] , using for fibromyalgia [device use issue] , my back is killing me/ back discomfort [back disorder] , shoulder discomfort [musculoskeletal discomfort] , swelling [swelling] , the areas underneath both wraps were red, inflamed, burned, and had rashes [erythema] , when she saw her rheumatologist he took her blood pressure and it was a little elevated [blood pressure increased] , skin irritation [skin irritation] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program (pfizer product refund program).A contactable consumer reported that a (b)(6) black (african american) female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) (device lot number: n97804, expiration date: apr2019) from (b)(6) 2016 for fibromyalgia, back pain and one wrap to shoulder for shoulder pain.Medical history included ongoing arthritis, pain (diagnosed with both probably over 6 years ago), ongoing osteoarthritis (in hands, 5 years, maybe less), ongoing fibromyalgia, ongoing chronic pain syndrome, post-menopausal was reported as no, she was still experiencing menopause, and sensitive skin.Concomitant medications included hydrocodone bitartrate, paracetamol (norco) 10-325mg tablet one every 4 to 6 hours for pain, and cyclobenzaprine, 10mg tablet at bedtime for pain.On (b)(6) 2016, the patient reported she applied the heatwrap directly to her skin for probably 3 or 4 hours and she kept breaking out and it was not helping in her pain.She stated she was all broken out on various parts of her body from where she had used the heatwrap with scratches she got from the itching and rash.The patient was hospitalized on an unspecified date in 2016 as a result of the events scratches, itching and rash.Upon received follow-up (20jan2017), the reporter further reported "my back is killing me".She also reported after using the product she had rashes, was severely burned and had shoulder and back discomfort.The patient experienced rash, burn, itching, swelling, inflammation on an unspecified date in (b)(6) 2016.She experienced shoulder discomfort, back discomfort on an unspecified date.The patient stated that around (b)(6) 2016 she applied a thermacare advanced joint pain therapy heatwrap to her shoulder and a thermacare back pain therapy heatwrap to her lower back.She had them in place for two to three hours, but then at work she started getting a stinging, burning feeling so went to remove the wraps and noticed that the areas underneath both wraps were red, inflamed, burned, and had rashes.The burn on her shoulder was worse than on her lower back.She applied aloe vera and that soothed the burning.The patient saw her rheumatologist and he prescribed a prednisone taper.She took four 10mg tablets for 3 days then three 10mg tablets for 3 days, then two 10mg tablets for 3 days, then one 10mg tablet for 3 days then stopped.It took a few days, but eventually the redness and inflammation went away.She still had marks where the burn and rashes were, but they were not burning or itching anymore.When she saw her rheumatologist he took her blood pressure and it was a little elevated because of the pain she was experiencing.The shoulder and back discomfort had been getting better, but for some reason last week it got really bad again.She just used a regular heating pad over her clothes, but that did not work.It has since gone back to feeling better.The patient had tried using aspercreme and capsaicin cream for shoulder and back discomfort in the past, but neither did anything for her.The patient assessed her skin tone as dark.She reported there were no defects in the wrap like cuts, tears, leaks or holes.The patient did not change or modify the wrap in any way.She did not put the wrap in the microwave and did not use the wrap overnight or while sleeping.The patient used the wrap over healthy skin and over the correct part of the body.She did not overlap the wrap and did not apply any pressure over the wrap.The patient did not wear more than 2 layers of clothing over the wrap and did not sit or recline for a prolonged period of time while using the wrap.She did not exercise while using the wrap and did not use more than one heatwrap per day.No abnormal skin conditions were reported.She did not think she had used it before.If she had, she did not have this reaction.She previously used an electric heating pad over her clothes shoulder and/or lower back pain as soon as she started sweating she would stop using it.She was wearing undergarments and clothing over the thermacare product.She did read the usage instructions on thermacare before she used the product.When the patient was asked how often did she check under the wrap, she answered she did not check it.Action taken with the suspect product was permanently withdrawn on an unspecified date.The outcome of the events burn/stinging/pain, itching, rash, scratches, shoulder discomfort was resolving.The outcome of swelling inflammation, redness was resolved on an unspecified date.The outcome of other events was unknown.As of (b)(6) 2017, the product quality complaint (pqc) group investigation results stated that the root cause category is non-assignable (complaint not confirmed).The cause of the alleged lack of effect defect is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Our 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.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.Additional information has been requested and will be provided as it becomes available.Follow up (08oct2016 and 10oct2016): new information received from product quality complaint includes: additional product lot number, reaction data (reported event terms of "fibromyalgia/did not check skin under heatwrap during use" were split and coded separately).Follow-up (17nov2016): new information received from a contactable consumer includes: updated suspect product start date and lot number, action taken with the suspect product and patient hospitalization required.Follow-up (20jan2017): new information received from a pfizer-sponsored program pfizer product refund program includes: added concomitant medications; new events burn/stinging/pain, inflammation, "my back is killing me/ back discomfort", shoulder discomfort, swelling, stinging/pain, redness, blood pressure a little elevated.Follow-up (22feb2017): new information reported from the pqc group includes: product investigation summary results.Follow-up (17mar2017): follow-up attempts completed.No further information expected.Follow-up (28mar2017): this contactable consumer reported by way of consumer follow-up questionnaire.This female patient used thermacare heatwrap (thermacare heatwraps multi-purpose joint pain) as directed on or around (b)(6) 2016 to painful area in arm shoulder (left) and lower middle of back for 2-3 hours for pain in back/ pain in left shoulder arm for one day.It was also reported that suspect product stopped on (b)(6) 2016.It was reported that product not heated in a microwave and applied the product directly on skin.The relevant medical history included pain since an unknown date (treated with hydrocodone, paracetamol (norco) 10-325 mg tablet, one every 4 to 6 hours since an unknown date and cyclobenzaprine 10 mg tablet once daily at bedtime on an unknown date) and arthritis since an unknown date (under medical care).The concomitant medication included hydrocodone, paracetamol (norco) since an unknown date.On an unknown date, she had skin irritation, broke outs and redness.On (b)(6) 2016, she had itching, was all broken out on various parts of her body, rash was all over her skin and used the wrap directly against her skin.The conditions itching and was all broken out on various parts of her body, rash was all over her skin were still experiencing.She was hospitalized on an unknown date for the event used the wrap directly against her skin.She received unknown medical treatment for event itching and unknown treatment for the event did not check skin under heatwrap during use and used the wrap directly against her skin.She was treated with prednisone 10 mg on an unknown date for 2 weeks for the events was all broken out on various parts of her body, rash was all over her skin and swelling.As of (b)(6) 2017, the clinical outcome of events itching and was all broken out on various parts of her body, rash was all over her skin was not recovered and skin irritation was unknown.
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