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| Device Problem
Patient-Device Incompatibility (2682)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); Irritation (1941); Red Eye(s) (2038); Increased Sensitivity (2065); Burning Sensation (2146); Tingling (2171); Ulcer (2274); Discomfort (2330); Reaction (2414)
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| Event Date 01/01/2018 |
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Event Type
Injury
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Event Description
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My hand has also developed a severe vasculitis [hypersensitivity vasculitis], tongue starts to tingle [paraesthesia oral], mouth burns [oral discomfort], burning sensation in her fingers and fingers burning [burning sensation], burning sensation in her eyes, nose, and throat/ burning in eyes, nose, throat [eye irritation], burning in eyes, nose, throat/burning sensation in her eyes, nose, and throat [nasal discomfort], burning sensation in her eyes, nose, and throat/ burning in eyes, nose, throat [throat irritation], throat tightening [throat tightness], allergic reaction [hypersensitivity], using lower back heatwrap for cramps [device use issue], the ulcers are very painful [skin ulcer], chemical sensitivities [allergy to chemicals], the residue must have been in the laundry, i made like a warm compress out of washed cloth, put it over my eye and it stung and i had firework, it was red [eye pain], the residue must have been in the laundry, i made like a warm compress out of washed cloth, put it over my eye and it stung and i had firework, it was red [ocular hyperaemia].Case narrative:this is a spontaneous report from two contactable consumers (patient's father and patient herself).This (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for cramps.Medical history included endometriosis from an unknown date and unknown if ongoing (diagnosed years ago), partial hysterectomy on an unspecified date in (b)(6) 2017 (she was in the process of recovering) and lyme disease from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.Patient's father stated that he had had a thermacare back pad that got into the washer in (b)(6) 2018.One of the cells broke and got all over the other clothes.The clothes went in the dryer.In the house, the clothes were on the furniture.There was one room upstairs that when his daughter went in it, her tongue started to tingle on (b)(6) 2018.When his daughter touched the clothes that hadn't been washed, she started getting a burning sensation in her fingers and fingers burning on (b)(6) 2018.It also reported if she held the clothes, she got a burning sensation/burning in her eyes, nose, throat and experiencing throat tightening when she entered the room where the heat cell broke apart on (b)(6) 2018.She experienced an allergic reaction in (b)(6) 2018.The patient's father stated he spoke with an environmental guy who told him to wash the clothes 6 times to get everything out.He was worried about the house.Now they were having issues with air quality.He stated that he was running commercial grade chemical air purifiers and it didn't seem to be doing anything.He bought a new washer and dryer because he was afraid there was residue in the back drum of the washer.The patient was still having the burning when she went into that room.He stated the house seemed to be getting better as he had the windows open and the air purifiers going.The suspect product had been discarded by his daughter.The patient reported on (b)(6) 2018 that her mouth burned on (b)(6) 2018.On an unspecified date in 2018, her hand had also developed a severe vasculitis - the hand she used to touch and worked with the laundry.The ulcers were very painful.Also she had severe chemical sensitivities.A large blue vein appeared & (illegible) the length of her face where exposed to certain chemicals, among other reactions.Consumer stated the residue must have been in the laundry, she made like a warm compress out of washed cloth, put it over her eye and it stung and she had firework, it was red in 2018.She had had a lot of things related ever since, she had had numerous health issues, thermacare heatwrap had a lot of health repercussion.Action taken with the suspect product was unknown.The patient was not admitted to hospital.Clinical outcome of the events burning sensation/burning in her eyes, nose, throat was resolving.Clinical outcome of the event burning sensation in her fingers and fingers burning, tongue starts to tingle, mouth burns and throat tightening was not resolved.Clinical outcome of the remaining events was unknown.Follow-up (22mar2018): new information received from a contactable consumer (patient) included: patient age, event details (including new events "hand has also developed a severe vasculitis", "mouth burns", "ulcers are very painful" and "severe chemical sensitivities" and event outcome).Follow-up (03apr2018): new information received from a contactable consumer (patient) includes: added new events "put it over my eye and it stung and i had firework, it was red".Follow-up (08mar2019): follow-up attempts are completed.No further information is expected.Follow-up (22mar2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the event hypersensitivity vasculitis as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the event hypersensitivity vasculitis as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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This investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 heat cells damaged/leaking.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.
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Event Description
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Event verbatim [preferred term] my hand has also developed a severe vasculitis [hypersensitivity vasculitis] , thermacare back pad got into the washer/one of the cells broke, got all over the other clothes/one room upstairs that when daughter went in it/touched the clothes that hadn't been washed [accidental exposure to product] , allergic reaction [hypersensitivity] , chemical sensitivities [allergy to chemicals] , the ulcers are very painful [skin ulcer] , throat tightening [throat tightness] , tongue starts to tingle [paraesthesia oral] , burning sensation in her eyes, nose, and throat/ burning in eyes, nose, throat [throat irritation] , mouth burns [oral discomfort] , burning sensation in her fingers and fingers burning [burning sensation] , burning sensation in her eyes, nose, and throat/ burning in eyes, nose, throat [eye irritation] , burning in eyes, nose, throat/burning sensation in her eyes, nose, and throat [nasal discomfort] , the residue must have been in the laundry, i made like a warm compress out of washed cloth, put it over my eye and it stung and i had firework, it was red [eye pain] , the residue must have been in the laundry, i made like a warm compress out of washed cloth, put it over my eye and it stung and i had firework, it was red [ocular hyperaemia] , using lower back heatwrap for cramps [device use issue].Case narrative:this is a spontaneous report from two contactable consumers (patient's father and patient herself).This 42-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for cramps.Medical history included endometriosis from an unknown date and unknown if ongoing (diagnosed years ago), partial hysterectomy on an unspecified date in (b)(6) 2017 (she was in the process of recovering) and lyme disease from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient's father stated that he had had a thermacare back pad that got into the washer in (b)(6) 2018.One of the cells broke and got all over the other clothes.The clothes went in the dryer.In the house, the clothes were on the furniture.There was one room upstairs that when his daughter went in it, her tongue started to tingle on (b)(6) 2018.When his daughter touched the clothes that hadn't been washed, she started getting a burning sensation in her fingers and fingers burning on (b)(6) 2018.It also reported if she held the clothes, she got a burning sensation/burning in her eyes, nose, throat and experiencing throat tightening when she entered the room where the heat cell broke apart on (b)(6) 2018.She experienced an allergic reaction in (b)(6) 2018.The patient's father stated he spoke with an environmental guy who told him to wash the clothes 6 times to get everything out.He was worried about the house.Now they were having issues with air quality.He stated that he was running commercial grade chemical air purifiers and it didn't seem to be doing anything.He bought a new washer and dryer because he was afraid there was residue in the back drum of the washer.The patient was still having the burning when she went into that room.He stated the house seemed to be getting better as he had the windows open and the air purifiers going.The suspect product had been discarded by his daughter.The patient reported on (b)(6) 2018 that her mouth burned on (b)(6) 2018.On an unspecified date in 2018, her hand had also developed a severe vasculitis - the hand she used to touch and worked with the laundry.The ulcers were very painful.Also she had severe chemical sensitivities.A large blue vein appeared & (illegible) the length of her face where exposed to certain chemicals, among other reactions.Consumer stated the residue must have been in the laundry, she made like a warm compress out of washed cloth, put it over her eye and it stung and she had firework, it was red in 2018.She had a lot of things related ever since, she had numerous health issues; thermacare heatwrap had a lot of health repercussion.Action taken with the suspect product was unknown.The patient was not admitted to hospital.The clinical outcomes of the events burning sensation/burning in her eyes, nose, throat were resolving.Clinical outcomes of the events burning sensation in her fingers and fingers burning, tongue starts to tingle, mouth burns and throat tightening were not resolved.The clinical outcomes of the remaining events were unknown.New information received from the product quality complaint group reports that there was a reasonable suspicion of a device malfunction.The impact was cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.This investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 heat cells damaged/leaking.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Follow-up (22mar2018): new information received from a contactable consumer (patient) included: patient age, event details (including new events "hand has also developed a severe vasculitis", "mouth burns", "ulcers are very painful" and "severe chemical sensitivities" and event outcome).Follow-up (03apr2018): new information received from a contactable consumer (patient) includes: added new events "put it over my eye and it stung and i had firework, it was red".Follow-up (08mar2019): follow-up attempts are completed.No further information is expected.Follow-up (22mar2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (13nov2019): new information received from a product quality complaint group included severity ranking.Follow-up (19nov2019): this is a follow-up report from a product quality complaint group included: investigation results.This case has been considered a reportable malfunction.Additionally, the previously reported, "thermacare back pad got into the washer/one of the cells broke, got all over the other clothes/one room upstairs that when daughter went in it/touched the clothes that hadn't been washed" was considered a reportable event due to accidental exposure.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events hypersensitivity vasculitis and accidental exposure to product as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events hypersensitivity vasculitis and accidental exposure to product as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Event Description
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Event verbatim [preferred term] my hand has also developed a severe vasculitis [hypersensitivity vasculitis] , using lower back heatwrap for cramps [device use issue] , tongue starts to tingle [paraesthesia oral] , mouth burns [oral discomfort] , burning sensation in her fingers and fingers burning [burning sensation] , burning sensation in her eyes, nose, and throat/ burning in eyes, nose, throat [eye irritation] , burning in eyes, nose, throat/burning sensation in her eyes, nose, and throat [nasal discomfort] , burning sensation in her eyes, nose, and throat/ burning in eyes, nose, throat [throat irritation] , throat tightening [throat tightness] , allergic reaction [hypersensitivity] , the ulcers are very painful [skin ulcer] , chemical sensitivities [allergy to chemicals] , the residue must have been in the laundry, i made like a warm compress out of washed cloth, put it over my eye and it stung and i had firework, it was red [eye pain] , the residue must have been in the laundry, i made like a warm compress out of washed cloth, put it over my eye and it stung and i had firework, it was red [ocular hyperaemia] ,.Case narrative:this is a spontaneous report from two contactable consumers (patient's father and patient herself).This 42-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for cramps.Medical history included endometriosis from an unknown date and unknown if ongoing (diagnosed years ago), partial hysterectomy on an unspecified date in (b)(6)
2017 (she was in the process of recovering) and lyme disease from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.Patient's father stated that he had had a thermacare back pad that got into the washer in (b)(6) 2018.One of the cells broke and got all over the other clothes.The clothes went in the dryer.In the house, the clothes were on the furniture.There was one room upstairs that when his daughter went in it, her tongue started to tingle on (b)(6) 2018.When his daughter touched the clothes that hadn't been washed, she started getting a burning sensation in her fingers and fingers burning on (b)(6) 2018.It also reported if she held the clothes, she got a burning sensation/burning in her eyes, nose, throat and experiencing throat tightening when she entered the room where the heat cell broke apart on (b)(6) 2018.She experienced an allergic reaction in (b)(6) 2018.The patient's father stated he spoke with an environmental guy who told him to wash the clothes 6 times to get everything out.He was worried about the house.Now they were having issues with air quality.He stated that he was running commercial grade chemical air purifiers and it didn't seem to be doing anything.He bought a new washer and dryer because he was afraid there was residue in the back drum of the washer.The patient was still having the burning when she went into that room.He stated the house seemed to be getting better as he had the windows open and the air purifiers going.The suspect product had been discarded by his daughter.The patient reported on (b)(6) 2018 that her mouth burned on (b)(6) 2018.On an unspecified date in 2018, her hand had also developed a severe vasculitis - the hand she used to touch and worked with the laundry.The ulcers were very painful.Also she had severe chemical sensitivities.A large blue vein appeared & (illegible) the length of her face where exposed to certain chemicals, among other reactions.Consumer stated the residue must have been in the laundry, she made like a warm compress out of washed cloth, put it over her eye and it stung and she had firework, it was red in 2018.She had had a lot of things related ever since, she had had numerous health issues, thermacare heatwrap had a lot of health repercussion.Action taken with the suspect product was unknown.The patient was not admitted to hospital.Clinical outcome of the events burning sensation/burning in her eyes, nose, throat was resolving.Clinical outcome of the event burning sensation in her fingers and fingers burning, tongue starts to tingle, mouth burns and throat tightening was not resolved.Clinical outcome of the remaining events was unknown.New information received including: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.Additional information has been requested and will be provided as it becomes available.Follow-up (22mar2018): new information received from a contactable consumer (patient) included: patient age, event details (including new events "hand has also developed a severe vasculitis", "mouth burns", "ulcers are very painful" and "severe chemical sensitivities" and event outcome).Follow-up (03apr2018): new information received from a contactable consumer (patient) includes: added new events "put it over my eye and it stung and i had firework, it was red".Follow-up (08mar2019): follow-up attempts are completed.No further information is expected.Follow-up (22mar2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (13nov2019): new information received from a product quality complaint group included severity ranking.Company clinical evaluation comment: based on the information provided, the event hypersensitivity vasculitis as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the event hypersensitivity vasculitis as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.
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