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| Lot Number T81948 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Swelling (2091); Patient Problem/Medical Problem (2688)
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| Event Date 04/08/2019 |
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Event Type
Injury
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Event Description
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Event verbatim (preferred term) two-euro-sized skin blister had formed (blister), at the same time the blister opened wound.Case narrative: this is a spontaneous report from a contactable pharmacist.This is a report received from the (b)(6).The regulatory authority report number is (b)(4).An (b)(6) years-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number t81948 02/14, expiration date not provided, from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.It was reported that 4 hours after the heatwrap was applied, an about two-euro-sized skin blister had formed.The wrap was removed immediately.At the same time the blister opened.After a few days, the blister healed after a wound treatment with a healing ointment.The patient had previously used thermacare more often without problems, but to the satisfaction.The action taken in response to the events for thermacare heatwrap was unknown.Therapeutic measures were taken as a result of both events.The outcome of the event two-euro-sized skin blister had formed was resolved and the outcome of the other event was unknown.Additional information has been requested and will be provided as it becomes available.
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Manufacturer Narrative
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Investigation summary for lot number t81948 which is as follows: 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 an adverse event due to blisters/burn.The cause of the adverse event 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.
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Event Description
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Event verbatim [preferred term] two-euro-sized skin blister had formed/on the back a 2 euro size blister filled with liquid, which opened and with scab formation/blisters/burn [burns second degree] , the skin around the blister respectively under the thermacare patch was reddened [application site erythema] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.This is a report received from the bfarm.The regulatory authority report number is 05012/19.An 81-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number t81948 (02/14), expiration date not provided, from 08apr2019 at unknown frequency for back pain.The patient medical history included heart disease.Concomitant medications included hydrochlorothiazide/ramipril (ramipril comp), hydrochlorothiazide/valsartan (valsacor comp), hydrochlorothiazide/metoprolol tartrate (metohexal comp) and simvastatin, all for heart disease (permanent medications).The patient had previously used thermacare more often and tolerated before, without problems, but to the satisfaction.It was reported that on 08apr2019, 4 hours after the heatwrap was applied, an about two-euro-sized skin blister had formed.The wrap was removed immediately.At the same time the blister opened.After a few days, the blister healed after a wound treatment with a healing ointment.It was also reported that "on the back a 2 euro size blister filled with liquid, which opened and with scab formation recovered.The skin around the blister respectively under the thermacare patch was reddened." the event occurred the first time.No surgical was needed; no long-term damage was to be expected.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on 08apr2019 due to the event.Therapeutic measures were taken as a result of event "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation".The outcome of the event "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation/blisters/burn" was resolved on 15apr2019.The outcome of the event "the skin around the blister respectively under the thermacare patch was reddened" was unknown.The events were considered as related by the pharmacist.The pharmacist later reported that "the patient did not visit a doctor, there was no diagnosis and no assessment of the event blister.Thus, no further statements can be made." on 03jun2019, product quality complaint group provided investigation summary for lot number t81948 which is as follows: 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 an adverse event due to blisters/burn.The cause of the adverse event 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.Follow-up (09may2019): this is a follow-up report to an existing report received initially from the bfarm.New information received from the same contactable pharmacist includes: product data (therapy dates, updated product trade name and indication), medical history, concomitant drugs and event data (onset date, reporter causality assessment and new event "the skin around the blister respectively under the thermacare patch was reddened" and additional event detail "the back a 2 euro size blister filled with liquid, which opened and with scab formation recovered").Follow-up (31may2019): this is a follow-up report to an existing report received initially from the bfarm.New information received from the same contactable pharmacist: patient did not visit a doctor, thus no diagnosis and no assessments.Follow-up (03jun2019): this is a follow-up report to an existing report received initially from the bfarm.New information received from product quality complaint group for lot# t81948: investigation summary and updated event (added "blisters/burn" verbatim term to events "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation" and combined the events into one event and recoded it to burn blister).No follow-up attempts are needed.No further information is expected.
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Event Description
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Event verbatim [preferred term] two-euro-sized skin blister had formed/on the back a 2 euro size blister filled with liquid, which opened and with scab formation [blister] , at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation [back injury] , the skin around the blister respectively under the thermacare patch was reddened [application site erythema] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.This is a report received from the bfarm.The regulatory authority report number is 05012/19.An 81-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number t81948 02/14, expiration date not provided, from 08apr2019 at unknown frequency for back pain.The patient medical history included heart disease.Concomitant medications included hydrochlorothiazide/ramipril (ramipril comp), hydrochlorothiazide/valsartan (valsacor comp), hydrochlorothiazide/metoprolol tartrate (metohexal comp) and simvastatin, all for heart disease (permanent medications).The patient had previously used thermacare more often and tolerated before, without problems, but to the satisfaction.It was reported that on 08apr2019, 4 hours after the heatwrap was applied, an about two-euro-sized skin blister had formed.The wrap was removed immediately.At the same time the blister opened.After a few days, the blister healed after a wound treatment with a healing ointment.It was also reported that "on the back a 2 euro size blister filled with liquid, which opened and with scab formation recovered.The skin around the blister respectively under the thermacare patch was reddened." the event occurred the first time.No surgical was needed; no long-term damage was to be expected.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on 08apr2019 due to the event.Therapeutic measures were taken as a result of events "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation".The outcome of the events "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation" was resolved on 15apr2019.The outcome of the event "the skin around the blister respectively under the thermacare patch was reddened" was unknown.The events were considered as related by the pharmacist.The pharmacist later reported that "the patient did not visit a doctor, there was no diagnosis and no assessment of the event blister.Thus, no further statements can be made." additional information has been requested and will be provided as it becomes available.Follow-up (09may2019): this is a follow-up report to an existing report received initially from the bfarm.New information received from the same contactable pharmacist includes: product data (therapy dates, updated product trade name and indication), medical history, concomitant drugs and event data (onset date, reporter causality assessment and new event "the skin around the blister respectively under the thermacare patch was reddened" and additional event detail "the back a 2 euro size blister filled with liquid, which opened and with scab formation recovered").Follow-up (31may2019): this is a follow-up report to an existing report received initially from the bfarm.New information received from the same contactable pharmacist: patient did not visit a doctor, thus no diagnosis and no assessments.No follow-up attempts are needed.No further information is expected.
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Event Description
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Event verbatim [preferred term] two-euro-sized skin blister had formed/on the back a 2 euro size blister filled with liquid, which opened and with scab formation [blister] , at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation [back injury] , the skin around the blister respectively under the thermacare patch was reddened [application site erythema] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.This is a report received from the bfarm.The regulatory authority report number is 05012/19.An 81-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t81948 02/14, expiration date not provided, from 08apr2019 at unknown frequency for back pain.The patient medical history included heart disease.Concomitant medications included hydrochlorothiazide, ramipril (ramipril comp), hydrochlorothiazide, valsartan (valsacor comp), hydrochlorothiazide, metoprolol tartrate (metohexal comp) and simvastatin, all for heart disease (permanent medications).It was reported that on (b)(6) 2019, 4 hours after the heatwrap was applied, an about two-euro-sized skin blister had formed.The wrap was removed immediately.At the same time the blister opened.After a few days, the blister healed after a wound treatment with a healing ointment.It was also reported that "on the back a 2 euro size blister filled with liquid, which opened and with scab formation recovered.The skin around the blister respectively under the thermacare patch was reddened." the event occurred the first time.No surgical was needed; no long-term damage was to be expected.The patient had previously used thermacare more often and tolerated before, without problems, but to the satisfaction.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2019 due to the event.Therapeutic measures were taken as a result of events "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation".The outcome of the events "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation" was resolved on 15apr2019.The outcome of the event "the skin around the blister respectively under the thermacare patch was reddened" was unknown.The report was considered as related by the pharmacist.Additional information has been requested and will be provided as it becomes available.Follow-up (09may2019): this is a follow-up report to an existing report received initially from the bfarm.New information received from the same contactable pharmacist includes: product data (therapy dates, updated product trade name and indication), medical history, concomitant drugs and event data (onset date, reporter causality assessment and new event "the skin around the blister respectively under the thermacare patch was reddened" and additional event detail "the back a 2 euro size blister filled with liquid, which opened and with scab formation recovered").
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The return sample evaluation was completed; there were no evidence to what caused the consumer to receive blisters.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports ¿a blister of approx 2.5 cm diameter (size of a 2 euro coin) formed".The cause of the burn and blisters 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 received sample and photos.Return sample evaluation: three wraps - wraps are inside sealed pouches.All three pouches are sealed - no obvious defects.Carton is open.
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Event Description
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Event verbatim [preferred term]: two-euro-sized skin blister had formed on the back.A 2 euro size blister filled with liquid, which opened and with scab formation/ blisters/ burn/ the skin around the blister respectively under the thermacare patch was reddened [burns second degree].Narrative: this is a spontaneous report from a contactable pharmacist.This is a report received from the (b)(6).The regulatory authority report number is 05012/19.An 81-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number t81948, expiration date: jan2021, from (b)(6) 2019 at unknown frequency for back pain.The patient medical history included heart disease.Concomitant medications included: hydrochlorothiazide/ramipril (ramipril comp), hydrochlorothiazide/valsartan (valsacor comp), hydrochlorothiazide/metoprolol tartrate (metohexal comp) and simvastatin, all for heart disease (permanent medications).The patient had previously used thermacare more often and tolerated before, without problems, but to the satisfaction.It was reported that on (b)(6) 2019, 4 hours after the heatwrap was applied, an about two-euro-sized skin blister had formed.The wrap was removed immediately.At the same time the blister opened.After a few days, the blister healed after a wound treatment with a healing ointment.It was also reported that "on the back, a 2 euro size blister filled with liquid, which opened and with scab formation recovered.The skin around the blister respectively under the thermacare patch was reddened".The event occurred the first time.No surgical was needed; no long-term damage was to be expected.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2019 due to the event.Therapeutic measures were taken as a result of event "at the same time the blister opened/on the back.A 2 euro size blister filled with liquid, which opened and with scab formation/blisters/burn/the skin around the blister respectively under the thermacare patch was reddened".The outcome of the event "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation/blisters/burn/the skin around the blister respectively under the thermacare patch was reddened" was resolved on (b)(6) 2019.The events were considered as related by the pharmacist.The pharmacist later reported that "the patient did not visit a doctor, there was no diagnosis and no assessment of the event blister.Thus, no further statements can be made".Product quality complaint group provided investigation summary for lot number t81948 which is as follows: the root cause category is non assignable (complaint not confirmed).The return sample evaluation was completed; there were no evidence to what caused the consumer to receive blisters.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "a blister of approx 2.5 cm diameter (size of a 2 euro coin) formed".The cause of the burn and blisters 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 received sample on (b)(6) 2019 and photos.Return sample evaluation: three wraps - wraps are inside sealed pouches.All three pouches are sealed - no obvious defects.Carton is open.Follow-up (09may2019): this is a follow-up report to an existing report received initially from the (b)(6).New information received from the same contactable pharmacist includes: product data (therapy dates, updated product trade name and indication), medical history, concomitant drugs and event data (onset date, reporter causality assessment and new event "the skin around the blister respectively under the thermacare patch was reddened" and additional event detail "the back a 2 euro size blister filled with liquid, which opened and with scab formation recovered").Follow-up (31may2019): this is a follow-up report to an existing report received initially from the (b)(6).New information received from the same contactable pharmacist: patient did not visit a doctor, thus no diagnosis and no assessments.Follow-up (03jun2019): this is a follow-up report to an existing report received initially from the (b)(6).New information received from product quality complaint group for lot# t81948: investigation summary and updated event (added "blisters/burn" verbatim term to events "at the same time the blister opened/on the back a 2 euro size blister filled with liquid, which opened and with scab formation" and combined the events into one event and recoded it to burn blister).No follow-up attempts are needed.No further information is expected.Follow-up (21sep2020): new information received from product quality complaint group includes device information (expiry date) and updated investigation results; this follow-up is also to amend previously reported information: "the skin around the blister respectively under the thermacare patch was reddened" was subsumed under second degree burn; device age captured as 4 hours.No follow-up attempts are needed.No further information is expected.
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