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| Lot Number W91247 |
| Device Problems
Difficult to Remove (1528); Use of Device Problem (1670); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Swelling (2091); Discomfort (2330); Partial thickness (Second Degree) Burn (2694)
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| Event Date 02/03/2019 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] has 3 big burns about the size of quarters and other welts/it burnt her back/blisters [burns second degree], wrap was sticking into her back [product adhesion issue].Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6)-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number w91247, expiration date may2021, udi number (b)(4), via an unspecified route of administration from 2015 to (b)(6) 2019 at 1 wrap to back as needed for sciatica and back problems.Medical history and concomitant medications were none.Consumer stated that she had worn these off and on since 2015 after she had sciatica and back problems and never had an issue.This was the first time this had ever happened.Consumer stated that she put patch on her back on sunday ((b)(6) 2019).When she took off patch, it burnt her back and she had blister on (b)(6) 2019.Consumer stated that she always wore the wraps over her underwear and never directly against her skin.Consumer stated that she had it on for about 4 hours.Consumer stated that she went to the bathroom and when she pulled down her underwear she said it felt like the wrap was sticking into her back.Consumer stated that she called her sister into the room who looked at her back and said it was burnt.Consumer stated that she was still in a lot of pain from the burn on monday, so she called her doctor.Consumer stated that went to the doctor on tuesday ((b)(6) 2019) who treated her for the burn and blisters.Consumer stated that the doctor bandaged it and gave her an ointment that she has to put on twice a day.Consumer stated that she just started treatment, so right now burn and blisters were the same; they were still there.Consumer stated that she has 3 big burns about the size of quarters and other welts.Consumer stated that she was really shocked by this because she had worn them periodically for sciatica since 2015 and this was the first time this had ever happened.Consumer stated that she even fell asleep one time with a wrap on and it did not do this.Consumer stated that she still had the wrap.Consumer stated that she did not throw it away and she also still had the second unopened wrap.Consumer stated that she had to pay money to see the doctor and get medication and it was still uncomfortable.The action taken in response to the event of the product was permanently discontinued.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burn blisters" and "product adhesive issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "burn blisters" and "product adhesive issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Event Description
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Has 3 big burns about the size of quarters and other welts/it burnt her back/blisters [burns second degree] , wrap was sticking into her back [product adhesion issue] , she did not check her skin frequently while using thermacare [device use error] , some skin spots were peeled off [skin exfoliation].Case narrative: this is a spontaneous report from a contactable consumer.This 66-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number w91247, expiration date may2021, udi number (b)(4), via an unspecified route of administration from (b)(6) 2019 to (b)(6) 2019 at 1 wrap to back as needed for sciatica and back pain.Medical history and concomitant medications were none.Consumer stated that she had previously worn these off and on since 2015 after she had sciatica and back problems and never had an issue.This was the first time this had ever happened.Consumer stated that she put patch on her back on sunday ((b)(6) 2019).When she took off patch, it burnt her back and she had blister on (b)(6) 2019.Consumer stated that she always wore the wraps over her underwear and never directly against her skin.Consumer stated that she had it on for about 4 hours.Consumer stated that she went to the bathroom and when she pulled down her underwear she said it felt like the wrap was sticking into her back.Consumer stated that she called her sister into the room who looked at her back and said it was burnt.Consumer stated that she was still in a lot of pain from the burn on monday so she called her doctor.Consumer stated that went to the doctor on tuesday ((b)(6) 2019) who treated her for the burn and blisters.Consumer stated that the doctor bandaged it and gave her an ointment that she has to put on twice a day.Consumer stated that she just started treatment, so right now burn and blisters were the same; they were still there.Consumer stated that she has 3 big burns about the size of quarters and other welts.Consumer stated that she was really shocked by this because she had worn them periodically for sciatica since 2015 and this was the first time this had ever happened.Consumer stated that she even fell asleep one time with a wrap on and it did not do this.Consumer stated that she still had the wrap.Consumer stated that she did not throw it away and she also still had the second unopened wrap.Consumer stated that she had to pay money to see the doctor and get medication and it was still uncomfortable.The action taken in response to the event of the product was permanently discontinued.The outcome of the event was not resolved.According to the product quality complaint group on 14mar2019 for lot number w91247: subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "3 big burns".The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.Follow-up (14mar2019): new information received from the product quality complaint group included investigational results and added "consumer stated that she even fell asleep one time with a wrap on and it did not do this" as additional event.Follow-up: (18mar2019): this is a follow-up report received from the same consumer via legal division.A 66-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number w91247, expiration date may2021 for lower back pain.Medical history included hypertension, severe obesity, chronic low back pain (>3 months), supracervical hysterectomy, chest pain, high density lipoprotein deficiency, breast lump, ganglion cyst, near syncope, tobacco smoker, and adult obstructive sleep apnea, moderate; non-alcohol user.Concomitant medications included mupirocin (bactroban) 2% ointment via topical applied the affected areas 2 times a day, topiramate (topamax) 25 mg tablet at 1 tablet by mouth 2 times a day, gabapentin (neurontin) 100mg capsule at 1 capsule by mouth daily at bedtime for 3 to 5 days, hydrocodone bitartrate, paracetamol (norco, hydrocodone bitartrate 5 mg/ paracetamol 325mg) at 1 tablet by mouth every 6 hours as needed for pain (cures check 20oct2018), atorvastatin calcium (lipitor) 20mg tablet at 1 tablet orally daily to prevent heart attacks and strokes; ciclosporin (restasis) 0.05% opht dropperette instill 1 drop in both eyes 2 times a day.The patient developed burning pain after using thermacare and discontinued using the product immediately on (b)(6) 2019.The diagnosis given by her doctor was burn and blisters and ointment was prescribed as treatment.She did not consult with her primary physician prior to usage of thermacare.She denied the following conditions: diabetes, poor circulation or hear disease, rheumatoid arthritis, pregnancy.She used the product for lower back pain for 3-4 hours on (b)(6) 2019.She applied the product on lower back on top of underwear.The product was not heated in a microwave prior to usage and not re-heated at all during usage.She would leave the product on 6-8 hours at one time during the course of 24 hours.She used it for 1 day.She did not leave the product on while sleeping.The skin was not damaged, broken, bruised or swelled prior to usage.She did not check her skin frequently while using thermacare.Thermacare was not used along with pain rubs, medicated lotions, creams or ointments.According to her doctor's report of the medical visit on (b)(6) 2019: the patient was here for blister and burn after she used the back heating pad for 5 hours after she took it off, some skin spots were peeled off.Objective on (b)(6) 2019: vital signs: bp 118/79, pulse 97, temperature: 97.7 fahrenheit (36.5 centigrade oral), weight: 105.7 kg, spo2 95%, body mass index (bmi): 42.62 kg/m2; physical examination: general appearance -vital signs reviewed and alert, well appearing, and in no distress.Eyes-pupils equal and reactive, extraocular eye movements intact; respiratory-clear to auscultation, no wheezes, rales or rhonchi, symmetric air entry; cardiovascular-normal rate and regular rhythm, normal s1, s2, no murmurs, rubs, clicks or gallops, peripheral pulse normal, no pedal edema, no clubbing or cyanosis; review of systems: eyes: negative blurred vision, cardiovascular: negative chest pain, pulmonary: negative shortness of breath.Assessment: burn (primary encounter diagnosis).Avoid rubbing; antibiotic ointment and gauze dressing; tylenol for pain.Plan: mupirocin 2 % top oint-apply to affected areas 2 times a day.The action taken in response to the event of the product was permanently discontinued on (b)(6) 2019.The outcome of the events "she did not check her skin frequently while using thermacare" and "some skin spots were peeled off" was unknown.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "3 big burns".The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.
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Event Description
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Event verbatim [preferred term] has 3 big burns about the size of quarters and other welts/it burnt her back/blisters [burns second degree] , wrap was sticking into her back [product adhesion issue] , she did not check her skin frequently while using thermacare [device use error] , some skin spots were peeled off [skin exfoliation] , burn mark which will be there forever and itching in the area [scar] , burn mark which will be there forever and itching in the area [itching scar].Case narrative:this is a spontaneous report from a contactable consumer.A 66-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number w91247, expiration date may2021, udi number (b)(4), via an unspecified route of administration from (b)(6) 2019 to (b)(6) 2019 at 1 wrap to back as needed for sciatica and lower back pain, and "to help with back cramps." medical history included hypertension, severe obesity, chronic low back pain (>3 months), supracervical hysterectomy, chest pain, high density lipoprotein deficiency, breast lump, ganglion cyst, near syncope, tobacco smoker, and adult obstructive sleep apnea, moderate, and non-alcohol user.Concomitant medications included mupirocin (bactroban) 2% ointment via topical applied the affected areas 2 times a day, oral topiramate (topamax) 25 mg tablet at 1 tablet 2 times a day, oral gabapentin (neurontin) 100mg capsule at 1 capsule daily at bedtime for 3 to 5 days, oral hydrocodone bitartrate/ paracetamol (norco, hydrocodone bitartrate 5 mg/ paracetamol 325mg) at 1 tablet every 6 hours as needed for pain (cures check 20oct2018), oral atorvastatin calcium (lipitor) 20mg tablet at 1 tablet daily to prevent heart attacks and strokes; ciclosporin (restasis) 0.05% ophthalmic 1 drop in both eyes 2 times a day.Patient had previously worn these off and on since 2015 after she had sciatica and back problems and never had an issue.The patient developed burning pain after using thermacare and discontinued using the product immediately on (b)(6) 2019.This was the first time this had ever happened.The patient put patch on her back on sunday (b)(6) 2019), and when she took off patch, it burnt her lower back and she had blister on (b)(6) 2019.It was reported that she always wore the wraps over/on top of her underwear and never directly against her skin.She had it on for about 4 hours (also reported for 3-4 hours) on (b)(6) 2019.She proceeded to prepare dinner etc.And went to the bathroom and when she pulled down her underwear it felt like the wrap was sticking into her back.Patient called her sister into the room who looked at her back and said it was burnt.Prior, she noticed "it was a little warmer but not excess." the patient was still in a lot of pain from the burn on monday so she called her doctor, and she went to the doctor on tuesday (b)(6) 2019) who treated her for the burn and blisters.The doctor bandaged it and gave her an ointment that she has to put on twice a day.It was reported that she just started treatment, so right now burn and blisters were the same; they were still there.Patient had 3 big burns about the size of quarters and other welts.Patient was really shocked by this because she had worn them periodically for sciatica since 2015 and this was the first time this had ever happened.Patient also reported that she even fell asleep one time with a wrap on and it did not do this.Patient still had the wrap, and that she did not throw it away and she also still had the second unopened wrap.It was still uncomfortable.On follow-up (b)(6) 2019, it was reported that "still have the burn mark which will be there forever and itching in the area".The diagnosis given by her doctor was burn and blisters and ointment was prescribed as treatment.According to her doctor's report of the medical visit on (b)(6) 2019: the patient was here for blister and burn after she used the back heating pad for 5 hours after she took it off, some skin spots were peeled off.Objective on (b)(6) 2019: vital signs: bp 118/79, pulse 97, temperature: 97.7 fahrenheit (36.5 centigrade oral), weight: 105.7 kg, spo2 95%, body mass index (bmi): 42.62 kg/m2; physical examination: general appearance -vital signs reviewed and alert, well appearing, and in no distress.Eyes-pupils equal and reactive, extraocular eye movements intact; respiratory-clear to auscultation, no wheezes, rales or rhonchi, symmetric air entry; cardiovascular-normal rate and regular rhythm, normal s1, s2, no murmurs, rubs, clicks or gallops, peripheral pulse normal, no pedal edema, no clubbing or cyanosis; review of systems: eyes: negative blurred vision, cardiovascular: negative chest pain, pulmonary: negative shortness of breath.Assessment: burn (primary encounter diagnosis).Avoid rubbing; antibiotic ointment and gauze dressing; paracetamol (tylenol) for pain.Plan: mupirocin 2 % top ointment-apply to affected areas 2 times a day.She did not consult with her primary physician prior to usage of thermacare.She denied the following conditions: diabetes, poor circulation or hear disease, rheumatoid arthritis, pregnancy.She applied the product on lower back on top of underwear.It was reported that she did not exercise while using the product.The product was not heated in a microwave prior to usage and not re-heated at all during usage.She would leave the product on 6-8 hours at one time during the course of 24 hours.She used it for 1 day.She did not leave the product on while sleeping.The skin was not damaged, broken, bruised or swelled prior to usage.She did not check her skin frequently while using thermacare.Thermacare was not used along with pain rubs, medicated lotions, creams or ointments.Patient classified her skin tone as dark or olive, did not have sensitive skin, and did not have abnormal skin conditions.The action taken in response to the event of the product was permanently discontinued on (b)(6) 2019.The outcome of the events "she did not check her skin frequently while using thermacare" and "some skin spots were peeled off" was unknown, and for the other events was not resolved.Product quality complaint group provided investigation summary on 14mar2019 for lot number w91247: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.Follow-up (14mar2019): new information received from the product quality complaint group included investigational results and added "consumer stated that she even fell asleep one time with a wrap on and it did not do this" as additional event.Follow-up (18mar2019): new information received from the same consumer via legal division includes: indication updated from back pain to lower back pain, medical history and concomitant medications (updated from none), device stop date, doctor's report of the medical visit with lab data, diagnosis, and information on treatment, and information on product use.Follow-up (26mar2019): new information received from the same consumer includes: additional indication (to help with back cramps), no exercise while using the product, event details (noticed a little warmer, lower back), skin type, and new events "still have the burn mark which will be there forever and itching in the area".
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "3 big burns".The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.
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Manufacturer Narrative
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Subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "3 big burns".The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.
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Event Description
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Event verbatim [preferred term] has 3 big burns about the size of quarters and other welts/it burnt her back/blisters [burns second degree] , wrap was sticking into her back [product adhesion issue] , consumer stated that she even fell asleep one time with a wrap on and it did not do this [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 66-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number w91247, expiration date may2021, udi number (b)(4), via an unspecified route of administration from (b)(6) 2019 to (b)(6) 2019 at 1 wrap to back as needed for sciatica and back pain.Medical history and concomitant medications were none.Consumer stated that she had previously worn these off and on since 2015 after she had sciatica and back problems and never had an issue.This was the first time this had ever happened.Consumer stated that she put patch on her back on sunday ((b)(6) 2019).When she took off patch, it burnt her back and she had blister on (b)(6) 2019.Consumer stated that she always wore the wraps over her underwear and never directly against her skin.Consumer stated that she had it on for about 4 hours.Consumer stated that she went to the bathroom and when she pulled down her underwear she said it felt like the wrap was sticking into her back.Consumer stated that she called her sister into the room who looked at her back and said it was burnt.Consumer stated that she was still in a lot of pain from the burn on monday so she called her doctor.Consumer stated that went to the doctor on tuesday ((b)(6) 2019) who treated her for the burn and blisters.Consumer stated that the doctor bandaged it and gave her an ointment that she has to put on twice a day.Consumer stated that she just started treatment, so right now burn and blisters were the same; they were still there.Consumer stated that she has 3 big burns about the size of quarters and other welts.Consumer stated that she was really shocked by this because she had worn them periodically for sciatica since 2015 and this was the first time this had ever happened.Consumer stated that she even fell asleep one time with a wrap on and it did not do this.Consumer stated that she still had the wrap.Consumer stated that she did not throw it away and she also still had the second unopened wrap.Consumer stated that she had to pay money to see the doctor and get medication and it was still uncomfortable.The action taken in response to the event of the product was permanently discontinued.The outcome of the event was not resolved.According to the product quality complaint group on 14mar2019 for lot number w91247: subclass: adverse event safety request for investigation.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "3 big burns".The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.Follow-up (14mar2019): new information received from the product quality complaint group included investigational results and added "consumer stated that she even fell asleep one time with a wrap on and it did not do this" as additional event.Company clinical evaluation comment: based on the information provided, the events of "burn blisters" and "product adhesive issue" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use error 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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn blisters" and "product adhesive issue" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use error 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.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Batch w91247 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request.For investigation received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "3 big burns".The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Site sample status was received at the site.Date samples were received: 11mar2019.Return sample evaluation: two wrap - one wrap is inside sealed pouch.One wrap shows evidence of wear.No obvious defects.Cell packs are hard; evidence of brine dosing.One pouch - (l)w91247 06/27; exp 2021-05 16:04; pouch is sealed - no obvious defects.One carton - (l) w91247 06/27; exp 2021-05 16:12.Carton is open.
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Event Description
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Event verbatim [preferred term] she did not check her skin frequently while using thermacare [device use error], has 3 big burns about the size of quarters and other welts/it burnt her back/blisters [burns second degree], wrap was sticking into her back [product adhesion issue], some skin spots were peeled off [skin exfoliation], burn mark which will be there forever and itching in the area [scar], burn mark which will be there forever and itching in the area [itching scar], , narrative: this is a spontaneous report from a contactable consumer.A 66-year-old female patient (non-pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), lot number w91247, expiration date may2021, udi number (b)(4), from (b)(6) 2019 at 1 wrap to back as needed for sciatica and lower back pain, and "to help with back cramps." medical history included hypertension (ongoing), severe obesity, chronic low back pain (>3 months), supracervical hysterectomy, chest pain, high density lipoprotein deficiency, breast lump, ganglion cyst, near syncope, tobacco smoker, and adult obstructive sleep apnea, moderate, and non-alcohol user (moderate).Concomitant medications included mupirocin (bactroban) 2% ointment via topical applied the affected areas 2 times a day, oral topiramate (topamax) 25 mg tablet at 1 tablet 2 times a day, oral gabapentin (neurontin) 100mg capsule at 1 capsule daily at bedtime for 3 to 5 days, oral hydrocodone bitartrate/ paracetamol (norco, hydrocodone bitartrate 5 mg/ paracetamol 325mg) at 1 tablet every 6 hours as needed for pain (cures check (b)(6) 2018), oral atorvastatin calcium (lipitor) 20mg tablet at 1 tablet daily to prevent heart attacks and strokes; ciclosporin (restasis) 0.05% ophthalmic 1 drop in both eyes 2 times a day.Patient had previously worn these off and on since 2015 after she had sciatica and back problems and never had an issue.The patient developed burning pain after using thermacare and discontinued using the product immediately on (b)(6) 2019.This was the first time this had ever happened.The patient put patch on her back on sunday ((b)(6) 2019), and when she took off patch, it burnt her lower back and she had blister on (b)(6) 2019.It was reported that she always wore the wraps over/on top of her underwear and never directly against her skin.She had it on for about 4 hours (also reported for 3-4 hours) on (b)(6) 2019.She proceeded to prepare dinner etc.And went to the bathroom and when she pulled down her underwear it felt like the wrap was sticking into her back.Patient called her sister into the room who looked at her back and said it was burnt.Prior, she noticed "it was a little warmer but not excess." the patient was still in a lot of pain from the burn on monday so she called her doctor, and she went to the doctor on tuesday ((b)(6) 2019) who treated her for the burn and blisters.The doctor bandaged it and gave her an ointment that she has to put on twice a day.It was reported that she just started treatment, so right now burn and blisters were the same; they were still there.Patient had 3 big burns about the size of quarters and other welts.Patient was really shocked by this because she had worn them periodically for sciatica since 2015 and this was the first time this had ever happened.Patient also reported that she even fell asleep one time with a wrap on and it did not do this.Patient still had the wrap, and that she did not throw it away and she also still had the second unopened wrap.It was still uncomfortable.On follow-up (b)(6) 2019, it was reported that "still have the burn mark which will be there forever and itching in the area".The diagnosis given by her doctor was burn and blisters and ointment was prescribed as treatment.According to her doctor's report of the medical visit on (b)(6) 2019: the patient was here for blister and burn after she used the back heating pad for 5 hours after she took it off, some skin spots were peeled off.Objective on (b)(6) 2019: vital signs: bp 118/79, pulse 97, temperature: 97.7 fahrenheit (36.5 centigrade oral), weight: 105.7 kg, spo2 95%, body mass index (bmi): 42.62 kg/m2; physical examination: general appearance -vital signs reviewed and alert, well appearing, and in no distress.Eyes-pupils equal and reactive, extraocular eye movements intact; respiratory-clear to auscultation, no wheezes, rales or rhonchi, symmetric air entry; cardiovascular-normal rate and regular rhythm, normal s1, s2, no murmurs, rubs, clicks or gallops, peripheral pulse normal, no pedal edema, no clubbing or cyanosis; review of systems: eyes: negative blurred vision, cardiovascular: negative chest pain, pulmonary: negative shortness of breath.Assessment: burn (primary encounter diagnosis).Avoid rubbing; antibiotic ointment and gauze dressing; paracetamol (tylenol) for pain.Plan: mupirocin 2 % top ointment-apply to affected areas 2 times a day.She did not consult with her primary physician prior to usage of thermacare.She denied the following conditions: diabetes, poor circulation or hear disease, rheumatoid arthritis, pregnancy.She applied the product on lower back on top of underwear.It was reported that she did not exercise while using the product.The product was not heated in a microwave prior to usage and not re-heated at all during usage.She would leave the product on 6-8 hours at one time during the course of 24 hours.She used it for 1 day.She did not leave the product on while sleeping on (b)(6) 2019.The skin was not damaged, broken, bruised or swelled prior to usage.She did not check her skin frequently while using thermacare on (b)(6) 2019.Thermacare was not used along with pain rubs, medicated lotions, creams or ointments.Patient classified her skin tone as dark or olive, did not have sensitive skin, and did not have abnormal skin conditions.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2019.The outcome of the events "she did not check her skin frequently while using thermacare" and "some skin spots were peeled off" was unknown, and for the other events was not resolved.Product quality complaint group provided investigation summary on 14mar2019 for lot number w91247: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related: no.Complaint confirmed: no.Design related: no.Notify safety: no.Follow-up (14mar2019): new information received from the product quality complaint group included investigational results and added "consumer stated that she even fell asleep one time with a wrap on and it did not do this" as additional event.Follow-up (18mar2019): new information received from the same consumer via legal division includes: indication updated from back pain to lower back pain, medical history and concomitant medications (updated from none), device stop date, doctor's report of the medical visit with lab data, diagnosis, and information on treatment, and information on product use.Follow-up (26mar2019): new information received from the same consumer includes: additional indication (to help with back cramps), no exercise while using the product, event details (noticed a little warmer, lower back), skin type, and new events "still have the burn mark which will be there forever and itching in the area".Follow-up (21sep2020): new information received from the product quality complaint group included updated investigational result.Batch w91247 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request.For investigation received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "3 big burns".The cause of the wrap causing burns is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Site sample status was received at the site.Date samples were received: 11mar2019.Return sample evaluation: two wrap - one wrap is inside sealed pouch.One wrap shows evidence of wear.No obvious defects.Cell packs are hard; evidence of brine dosing.One pouch - (l)w91247 06/27; exp 2021-05 16:04; pouch is sealed - no obvious defects.One carton - (l) w91247 06/27; exp 2021-05 16:12.Carton is open.
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