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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Event Description
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Burn of neck/burn blister [burns second degree].Case narrative: this is a spontaneous report from a pfizer-sponsored program [brand websites for "devision" consumer healthcare (b)(4)] from a contactable consumer.This male consumer of unknown age started to receive thermacare heatwrap (thermacare fuer flexible anwendung) from unknown date for unknown indication.Medical history and concomitant medications were not reported.Consumer stated "one of your thermacare flexible products caused burns in the neck area to me.Can i hope in this regard for a compensation in the form of free products, because in general i am very satisfied with thermacare".A picture was provided which showed a burn blister (approximately: 1.9 cm x 1cm) with erythema around it.The smallest width of the erythema was about 2 mm, the largest about 6 mm.The lesion appeared to be on the borderline to the hairline.It could not be excluded that part of the erythema in the posterior part of the lesion was covered by hair.Treatment was received for the event burn blister.The action taken in response to the event of the product was unknown.The outcome of the event 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 event of burns second degree as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Burn of neck/burn blister [burns second degree], did not control skin during use of thermacare [intentional device misuse].Case narrative: this is a spontaneous report from a pfizer-sponsored program [brand websites for devision consumer healthcare germany] from a contactable consumer.This 49-year-old male consumer started to receive thermacare heatwrap (thermacare fuer flexible anwendung) from unknown date as needed for tension in neck.Medical history included ongoing diabetes.Concomitant medications included metformin hydrochloride (metformin 1a pharma), empagliflozin (jardiance), metoprolol tartrate (metoprolol 1a pharma), sitagliptin phosphate (xelevia), venlafaxine hydrochloride (venlafaxin 1a pharma), simvastatin (simvastatin 1a pharma), biotin, calcium pantothenate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, vitamin b1 nos, vitamin b12 nos (vitamin b komplex dr.Wagner), candesartan cilexetil, hydrochlorothiazide (candesartan abz comp) and chlorprothixene (chlorprothixen holsten).Consumer stated "one of your thermacare flexible products caused burns in the neck area to me.(see photo after the medical treatment) can i hope in this regard for a compensation in the form of free products, because in general i am very satisfied with thermacare".A picture was provided which showed a burn blister (approximately: 1.9 cm x 1cm) with erythema around it.The smallest width of the erythema was about 2 mm, the largest about 6 mm.The lesion appeared to be on the borderline to the hairline.It could not be excluded that part of the erythema in the posterior part of the lesion was covered by hair.The patient had fair skin, no sensitive skin, no skin disease, the package of thermacare was red, the product was used completely, thermacare was used for 12 hours, thermacare had been used before without similar intolerances, patient had also already used other heat-developing products for pain therapy, no intolerances occurred under these products, patient slept during use of thermacare, patient used thermacare directly on body, patient did not exercise during use, patient did not control skin during use of thermacare, patient read the user instructions before use, event was described as "burn second to third degree in neck".The patient consulted a physician due to event.Treatment received for the event burn blister included first care and bandage.The action taken in response to the event of the product was unknown.The outcome of the event was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (06feb2019): new information from contactable consumer included: patient data (age, weight, height), suspect product data (frequency, indication), medical history, past drug history, concomitant medications, treatment received and new event (did not control skin during use of thermacare).Company clinical evaluation comment: based on the information provided, the event of "burns second degree" and "did not control skin during use of thermacare" as described are considered serious bodily injury 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 event of "burns second degree" and "did not control skin during use of thermacare" as described are considered serious bodily injury 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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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).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.There is not a trend identified for the subclass of adverse event safety request for investigation for flexible use products.
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Event Description
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Burn of neck/burn blister/burn second to third degree in neck [burns second degree], burn of neck/burn blister/burn second to third degree in neck [burns third degree], patient read the user instructions before use/ did not control skin during use of thermacare [intentional device misuse].Case narrative: this is a spontaneous report from a pfizer-sponsored program [brand websites for devision consumer healthcare germany] from a contactable consumer.This 49-year-old male patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung) from unknown date as needed for tension in neck.Medical history included ongoing diabetes, restlessness and sleep disorder.Concomitant medications included metformin hydrochloride (metformin 1a pharma) strength 1000, unit unknown, at 0.5 tablet three time a day; empagliflozin (jardiance) strength 25mg, 1 tablet in the morning; metoprolol tartrate (metoprolol 1a pharma) "strength" 50, unit unknown, at 1.5 tablet in the morning and in the evening; sitagliptin phosphate (xelevia) strength 100mg, 1 film-coated tablet in the morning; venlafaxine hydrochloride (venlafaxin 1a pharma) strength 75mg, 1 tablet in the "morning"; simvastatin (simvastatin 1a pharma) strength 40mg, 1 film-coated tablet in the morning; biotin, calcium pantothenate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, vitamin b1 nos, vitamin b12 nos (vitamin b komplex dr.(b)(6)) 1 capsule once a day; candesartan cilexetil, hydrochlorothiazide (candesartan abz comp) strength: 16/12.5mg, 1 tablet in the morning and chlorprothixene (chlorprothixen holsten) 1-3 tablets as needed for restlessness and sleep disorder.Consumer stated "one of your thermacare flexible products caused burns in the neck area to me.(see photo after the medical treatment) can i hope in this regard for a compensation in the form of free products, because in general i am very satisfied with thermacare".A picture was provided which showed a burn blister (approximately: 1.9 cm x 1cm) with erythema around it.The smallest width of the erythema was about 2 mm, the largest about 6 mm.The lesion appeared to be on the borderline to the hairline.It could not be excluded that part of the erythema in the posterior part of the lesion was covered by hair.The patient had fair skin, no sensitive skin, no skin disease, the package of thermacare was red, the product was used completely, thermacare was used for 12 hours, thermacare had been used before without similar intolerances, patient had also already used other heat-developing products for pain therapy, no intolerances occurred under these products.Patient slept during use of thermacare, patient used thermacare directly on body, patient did not exercise during use, patient did not control skin during use of thermacare, patient read the user instructions before use, event was described as "burn second to third degree in neck".The patient consulted a physician due to event.Treatment received for the event burn blister included first care and bandage.The action taken in response to the events of the product was unknown.The outcome of the event burn of neck/burn blister was not resolved.The outcome of "the" event was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).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.There is not a trend identified for the subclass of adverse event safety request for investigation for flexible use products.Follow-up (06feb2019): new information from contactable consumer included: patient data (age, weight, height), suspect product data (frequency, indication), medical history, past drug history, concomitant medications, treatment received and new event (did not control skin during use of thermacare).Follow-up (20feb2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the events of burns second degree, burns third degree and intentional device misuse as described are considered serious bodily injury 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.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.In the case narrative, there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events of burns second degree, burns third degree and intentional device misuse as described are considered serious bodily injury 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.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.In the case narrative, there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Search Alerts/Recalls
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