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| Lot Number L92682 |
| Patient Problems
Discharge (2225); Wheal(s) (2241); Urticaria (2278); Reaction (2414); Burn, Thermal (2530)
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| Event Date 02/20/2016 |
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Event Type
Injury
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Event Description
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At the front of the abdomen, where the velcro is closed: feels like a burn [thermal burn].At the front of the abdomen, where the velcro is closed: extreme skin reaction [skin reaction].At the front of the abdomen, where the velcro is closed: weeping [wound secretion].At the front of the abdomen, where the velcro is closed: wheals [urticaria].Case description: this is a spontaneous report from a pharmacist received via costumer care center.A (b)(6) female patient used thermacare heatwrap (thermacare lower back & hip, lot # not reported) once on (b)(6) 2016 for back pain.The patient's medical history and concomitant medications were not reported.On (b)(6) 2016, the reporter stated the patient experienced "at the front of the abdomen, where the velcro is closed: extreme skin reaction, weeping, feels like a burn, wheals.At the back where the wrap rests itself, everything was normal." the pharmacist provided seriousness criterion "medical or surgical acute action required" (intervention required).No causality was provided.Action taken with the suspect product was unknown.Clinical outcome of the events 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 "at the front of the abdomen, where the velcro is closed: extreme skin reaction, weeping, feels like a burn, wheals" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin reaction, weeping, feels like a burn, wheals" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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Case description: this is a spontaneous report from a pharmacist received via costumer care center.A (b)(6) female patient of unspecified ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: l92682, expiration date: apr2020) once on (b)(6) 2016 for back pain.The patient's medical history and concomitant medications were not reported.On (b)(6) 2016, the reporter stated the patient experienced "at the front of the abdomen, where the velcro is closed: extreme skin reaction, weeping, feels like a burn, wheals.At the back where the wrap rests itself, everything was normal." the patient was in intensive contact with her dermatologist for wound care and treatment.The pharmacist provided seriousness criterion "medical or surgical acute action required" (intervention required).No causality was provided.Action taken with the suspect product was unknown.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (02mar2016): new information received from a pharmacist includes: patient details, suspect product lot number, expiration date and event outcome.Company clinical evaluation comment based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin reaction, weeping, feels like a burn, wheals" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin reaction, weeping, feels like a burn, wheals" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.
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Event Description
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At the front of the abdomen, where the velcro is closed: feels like a burn [thermal burn].At the front of the abdomen, where the velcro is closed: extreme skin rash [rash].At the front of the abdomen, where the velcro is closed: weeping [wound secretion].At the front of the abdomen, where the velcro is closed: wheals [urticaria].Case description: this is a spontaneous report from a pharmacist received via costumer care center.A (b)(6) year-old female patient of unspecified ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: l92682, expiration date: apr2020) once on (b)(6) 2016 for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.On (b)(6) 2016, the reporter stated the patient administered the heatwrap for about 2 hours and experienced "at the front of the abdomen (at the waistband), where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals.At the back where the wrap rests itself, everything was normal." the events appeared directly after the 2 hours of heatwrap usage.This was the initial use of the heatwrap by the patient.The patient was in intensive contact with her dermatologist for wound care and treatment.The reporter stated the active ingredient for the relief of back pain was tolerated, the velcro led to the undesirable effects.It was unknown whether the patient would have long-term damage, such as scarring.No causality was provided.The patient had no underlying diseases.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.No surgical intervention was necessary.Treatment by the physician included an unspecified wound ointment and sterile wound compresses applied to the affected skin area.Clinical outcome of the events was not resolved.Additional information received from the drug commission of the (b)(6) pharmacists includes: the internal number of the drug commission of the german pharmacists ((b)(6)) and a number of the regulatory authority ((b)(6)).Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2016): new information received from a pharmacist includes: patient details, suspect product lot number, expiration date and event outcome.Follow-up ((b)(6) 2016): new information received from the contactable pharmacist includes: no concomitant medications, action taken with suspect product, suspect product stop date, therapeutic measures taken and reaction data (even skin reaction updated to skin rash).Company clinical evaluation comment based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets follow up10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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Case description: this is a spontaneous report from a pharmacist received via costumer care center.A (b)(6)-year-old female patient of an unspecified ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: l92682, expiration date: apr2020) once on (b)(6) 2016 for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.On (b)(6) 2016, the reporter stated the patient administered the heatwrap for about 2 hours and experienced "at the front of the abdomen (at the waistband), where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals.At the back where the wrap rests itself, everything was normal." the events appeared directly after the 2 hours of heatwrap usage.This was the initial use of the heatwrap by the patient.The patient was in intensive contact with her dermatologist for wound care and treatment.The reporter stated the active ingredient for the relief of back pain was tolerated, the velcro led to the undesirable effects.It was unknown whether the patient would have long-term damage, such as scarring.No causality was provided.The patient had no underlying diseases.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.No surgical intervention was necessary.Treatment by the physician included an unspecified wound ointment and sterile wound compresses applied to the affected skin area.Clinical outcome of the events was not resolved.Additional information received from the drug commission of the (b)(4) pharmacists includes: the internal number of the drug commission of the (b)(4) pharmacists (b)(4 and a number of the regulatory authority (b)(4).New information received from product quality complaint (pqc) group includes investigation results.The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (02mar2016): new information received from a pharmacist includes: patient details, suspect product lot number, expiration date and event outcome.Follow-up (07mar2016): new information received from the contactable pharmacist includes: no concomitant medications, action taken with suspect product, suspect product stop date, therapeutic measures taken and reaction data (even skin reaction updated to skin rash).Follow-up (08mar2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals" as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets follow up10-day (b)(4) and 30-day fda reportability.Continued: evaluation summary: the plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.
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Event Description
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At the front of the abdomen, where the velcro is closed: feels like a burn [thermal burn].At the front of the abdomen, where the velcro is closed: extreme skin rash [rash].At the front of the abdomen, where the velcro is closed: weeping [wound secretion].At the front of the abdomen, where the velcro is closed: wheals [urticaria].Corrosive injury [chemical injury].Open wound [wound].Case description: this is a spontaneous report from a pharmacist received via customer care center.A (b)(6) female patient of an unspecified ethnicity used thermacare heatwrap (thermacare lower back and hip) (lot #: l92682, expiration date: apr2020) once on (b)(6) 2016 for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.On (b)(6) 2016, the reporter stated the patient administered the heatwrap for about 2 hours and experienced "at the front of the abdomen (at the waistband), where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals.At the back where the wrap rests itself, everything was normal." the events appeared directly after the 2 hours of heatwrap usage.This was the initial use of the heatwrap by the patient.The patient was in intensive contact with her dermatologist for wound care and treatment.The reporter stated the active ingredient for the relief of back pain was tolerated, the velcro led to the undesirable effects.It was unknown whether the patient would have long-term damage, such as scarring.No causality was provided.The patient had no underlying diseases.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.No surgical intervention was necessary.Treatment by the physician included an unspecified wound ointment and sterile wound compresses applied to the affected skin area.Clinical outcome of the events was not resolved.Upon follow-up on (b)(6) 2016, the pharmacist stated the patient still had an open wound caused by burn/corrosive injury.The treating physician confirmed the diagnosis corrosive injury.Additional information received from the (b)(6) includes: the internal number of (b)(6) (b)(4) and a number of the regulatory authority (b)(4).New information received from product quality complaint (pqc) group includes investigation results.The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (02mar2016): new information received from a pharmacist includes: patient details, suspect product lot number, expiration date and event outcome.Follow-up (07mar2016): new information received from the contactable pharmacist includes: no concomitant medications, action taken with suspect product, suspect product stop date, therapeutic measures taken and reaction data (even skin reaction updated to skin rash).Follow-up (08mar2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (11mar2016): new information received from the contactable pharmacist includes: reaction data (additional events of open wound and corrosive injury).Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals," open wound and corrosive injury as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals," open wound and corrosive injury as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.
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Event Description
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Corrosive injury [chemical injury], at the front of the abdomen, where the velcro is closed: extreme skin rash [rash], at the front of the abdomen, where the velcro is closed: weeping [wound secretion], at the front of the abdomen, where the velcro is closed: wheals [urticaria], open wound [wound], velcro caused the event which was applied directly to skin of the abdomen [skin abrasion], velcro caused the event which was applied directly to skin of the abdomen, did not check skin under the product, wore for 10 hours [intentional device misuse], scar [scar].Case description: this is a spontaneous report from a pharmacist received via costumer care center.A (b)(6) female patient of an unspecified ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: l92682, expiration date: apr2020) once on (b)(6) 2016 for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.On (b)(6) 2016, the reporter stated the patient administered the heatwrap for about 2 hours and experienced "at the front of the abdomen (at the waistband), where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals.At the back where the wrap rests itself, everything was normal." the events appeared directly after the 2 hours of heatwrap usage.This was the initial use of the heatwrap by the patient.Velcro caused the event which was applied directly to skin of the abdomen.The patient was in intensive contact with her dermatologist for wound care and treatment.The reporter stated the active ingredient for the relief of back pain was tolerated, the velcro led to the undesirable effects.It was unknown whether the patient would have long-term damage, such as scarring.No causality was provided.The patient had no underlying diseases.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.No surgical intervention was necessary.Treatment by the physician included an unspecified wound ointment and sterile wound compresses applied to the affected skin area.Clinical outcome of the events was not resolved.Upon follow-up on (b)(6) 2016, the pharmacist stated the patient still had an open wound caused by burn/corrosive injury.The treating physician confirmed the diagnosis corrosive injury.Additional information received from the drug commission of the german pharmacists includes: (b)(4).New information received from product quality complaint (pqc) group includes investigation results.The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (02mar2016): new information received from a pharmacist includes: patient details, suspect product lot number, expiration date and event outcome.Follow-up (07mar2016): new information received from the contactable pharmacist includes: no concomitant medications, action taken with suspect product, suspect product stop date, therapeutic measures taken and reaction data (even skin reaction updated to skin rash).Follow-up (08mar2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (11mar2016): new information received from the contactable pharmacist includes: reaction data (additional events of open wound and corrosive injury).Follow-up (23mar2016): this follow-up report is being submitted to amend previously reported information: event of burn subsumed under event corrosive injury.Follow up (13apr2016): this follow up report is being submitted to amend previously reported information: the events of skin abrasion and intentional device misuse were added.Follow-up attempts completed.No further information expected.Follow-up (15apr2016): this is a follow-up report to notify that (b)(4) are duplicates.All subsequent follow-up information will be reported under (b)(4).Case (b)(4) is being deleted from the database.This is a spontaneous report from a contactable consumer and her health insurance company.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2016, the patient reported buying the product in a pharmacy and administered it for about 10 hours.On (b)(6) 2016, an approximately walnut-sized wound on the abdomen developed, where the patch closure was.Upon follow up, the patient's health insurance company reported "the patient experienced an injury to health on (b)(6) 2016.The patient bought a thermacare heatwrap back in the pharmacy.After wearing this heatwrap a walnut size burn appeared on the skin." on (b)(6) 2016, she visited her general practitioner.After a thorough examination, he prescribed compresses and a wound and healing ointment.Because the wound was heavily exuding, she had to bandage it several times a day.On (b)(6) 2016, she visited a dermatologist.She prescribed a skin antibiotic, fusicutan ointment.On (b)(6) 2016, she had another appointment with her general practitioner for an examination.The therapy was still not complete.As a precaution, she had also informed the regulatory authority bfarm about it.Action taken with the suspect product was unknown.Therapeutic measures taken included compresses, unspecified wound and healing ointment, bandages and skin antibiotic fusicutan ointment.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow up (08apr2016): new information received from a health insurance company of the patient included patient's date of birth and reaction data (onset date of event and additional event "after wearing this heatwrap a walnut size burn appeared on the skin").Company clinical evaluation comment: based on the information provided, the events of "walnut-sized burn, heavily exuding wound on the abdomen, where the patch-closure was" as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The device misuse is assessed as non-serious and assessed as associated with the use of the device.This case meets follow-up 10-day eu and 30-day fda reportability.Follow-up (18apr2016): new information received from the same contactable consumer included: the female patient used thermacare heatwrap (thermacare lower back & hip) (lot #: l92682, expiration date: apr2020 , also reported as mar2018) on (b)(6) 2016 from 10 am to 6 pm for back pain.Relevant medical history included cardiomyopathy.Concomitant medications included bisoprolol 5 mg, 1 tablet, 1x/day for cardiomyopathy and candesartan 8 mg, 0.5 tablet, 1x/day for cardiomyopathy.The female patient experienced a walnut size, exuding wound at the abdomen due to the velcro (where the patch closure was) on (b)(6) 2016.She was not hospitalized, but was treated with compresses.The scar persists.She was not pregnant and is not in menopause.The patient is not currently under the care of a physician for any medical condition.She as medium skin tone.She does not have sensitive skin or abnormal skin conditions.The lot number was l92682 and expiration date was mar2018.Thermacare start date: (b)(6) 2016 at 10 am and thermacare stop date: (b)(6) 2016 at 6 pm.Number of days in a row that thermacare was used: 1.Number of hours per day that thermacare was used: 8 hours (also reported as 10 hours).The patient previously used thermacare once, a long time ago and the same problem was not experienced.The patient previously used a hot water bottle sporadically.She attached the adhesive to her body.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare.She did read the usage instructions on thermacare before using the product.The patient reported the next day after applying, noticed the wound at the abdomen, 5 weeks until healing, scar now.The outcome of the event scar is not resolved, the outcome of walnut size burn on the skin is resolved.The action taken with thermacare heatwrap was permanently withdrawn.The patient consulted a pharmacist and physician.Treatment included beoanthen and fusicutan ointment, compresses.She also reported on (b)(6) 2016 she visited her general practitioner.He prescribed me after a thorough examination compresses and a wound and healing ointment.Because the wound was heavily exuding, she had to bandage the wound several times a day.On (b)(6) 2016 she visited a dermatologist.She prescribed a skin antibiotic, fusicutan ointment.On (b)(6) 2016 she had another appointment with her general practitioner for examination.The therapy was still not complete.Company clinical evaluation comment: based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals", open wound, scar, corrosive injury and velcro caused the events which was applied directly to skin of the abdomen as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated to the velcro part of the device.The device functioned as designed but was used inappropriately by the (b)(6) patient, who directly applied the device to her skin.No device malfunction has been identified.Case comment: based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals", open wound, scar, corrosive injury and velcro caused the events which was applied directly to skin of the abdomen as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated to the velcro part of the device.The device functioned as designed but was used inappropriately by the (b)(6) patient, who directly applied the device to her skin.No device malfunction has been identified.
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Event Description
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Corrosive injury [chemical injury].At the front of the abdomen, where the velcro is closed: extreme skin rash [rash].At the front of the abdomen, where the velcro is closed: weeping [wound secretion].At the front of the abdomen, where the velcro is closed: wheals [urticaria].Open wound [wound].Case description: this is a spontaneous report from a pharmacist received via costumer care center.A (b)(6)-year-old female patient of an unspecified ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: l92682, expiration date: apr 2020) once on (b)(6) 2016 for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.On (b)(6) 2016, the reporter stated the patient administered the heatwrap for about 2 hours and experienced "at the front of the abdomen (at the waistband), where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals.At the back where the wrap rests itself, everything was normal." the events appeared directly after the 2 hours of heatwrap usage.This was the initial use of the heatwrap by the patient.The patient was in intensive contact with her dermatologist for wound care and treatment.The reporter stated the active ingredient for the relief of back pain was tolerated, the velcro led to the undesirable effects.It was unknown whether the patient would have long-term damage, such as scarring.No causality was provided.The patient had no underlying diseases.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.No surgical intervention was necessary.Treatment by the physician included an unspecified wound ointment and sterile wound compresses applied to the affected skin area.Clinical outcome of the events was not resolved.Upon follow-up on (b)(6) 2016, the pharmacist stated the patient still had an open wound caused by burn/corrosive injury.The treating physician confirmed the diagnosis corrosive injury.Additional information received from the (b)(4) includes: the internal number of the (b)(4) and a number of the regulatory authority (b)(4).New information received from product quality complaint (pqc) group includes investigation results.The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (02mar2016): new information received from a pharmacist includes: patient details, suspect product lot number, expiration date and event outcome.Follow-up (07mar2016): new information received from the contactable pharmacist includes: no concomitant medications, action taken with suspect product, suspect product stop date, therapeutic measures taken and reaction data (even skin reaction updated to skin rash).Follow-up (08mar2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (11mar2016): new information received from the contactable pharmacist includes: reaction data (additional events of open wound and corrosive injury).Follow-up (23mar2016): this follow-up report is being submitted to amend previously reported information: event of burn subsumed under event corrosive injury.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals", open wound and corrosive injury as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.
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Event Description
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Corrosive injury [chemical injury].At the front of the abdomen, where the velcro is closed: extreme skin rash [rash].At the front of the abdomen, where the velcro is closed: weeping [wound secretion].At the front of the abdomen, where the velcro is closed: wheals [urticaria].Open wound [wound].Velcro caused the event which was applied directly to skin of the abdomen [skin abrasion].Velcro caused the event which was applied directly to skin of the abdomen [intentional device misuse].Case description: this is a spontaneous report from a pharmacist received via customer care center.A (b)(6)-year-old female patient of an unspecified ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: l92682, expiration date: apr2020) once on (b)(6) 2016 for back pain.The patient's medical history was not reported.Concomitant medications were reported as none.On (b)(6) 2016, the reporter stated the patient administered the heatwrap for about 2 hours and experienced "at the front of the abdomen (at the waistband), where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals.At the back where the wrap rests itself, everything was normal." the events appeared directly after the 2 hours of heatwrap usage.This was the initial use of the heatwrap by the patient.Velcro caused the event which was applied directly to skin of the abdomen.The patient was in intensive contact with her dermatologist for wound care and treatment.The reporter stated the active ingredient for the relief of back pain was tolerated, the velcro led to the undesirable effects.It was unknown whether the patient would have long-term damage, such as scarring.No causality was provided.The patient had no underlying diseases.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.No surgical intervention was necessary.Treatment by the physician included an unspecified wound ointment and sterile wound compresses applied to the affected skin area.Clinical outcome of the events was not resolved.Upon follow-up on (b)(6) 2016, the pharmacist stated the patient still had an open wound caused by burn/corrosive injury.The treating physician confirmed the diagnosis corrosive injury.(b)(6).New information received from product quality complaint (pqc) group includes investigation results.The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (02mar2016): new information received from a pharmacist includes: patient details, suspect product lot number, expiration date and event outcome.Follow-up (07mar2016): new information received from the contactable pharmacist includes: no concomitant medications, action taken with suspect product, suspect product stop date, therapeutic measures taken and reaction data (even skin reaction updated to skin rash).Follow-up (08mar2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (11mar2016): new information received from the contactable pharmacist includes: reaction data (additional events of open wound and corrosive injury).Follow-up (23mar2016): this follow-up report is being submitted to amend previously reported information: event of burn subsumed under event corrosive injury.Follow up (13apr2016): this follow up report is being submitted to amend previously reported information: the events of skin abrasion and intentional device misuse were added.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals", open wound, corrosive injury and velcro caused the event which was applied directly to skin of the abdomen as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated to the velcro part of the device.The device functioned as designed but was used inappropriately by the (b)(6) year old patient who directly applied the device to her skin.No device malfunction has been identified.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events "at the front of the abdomen, where the velcro is closed: extreme skin rash, weeping, feels like a burn, wheals", open wound, corrosive injury and velcro caused the event which was applied directly to skin of the abdomen as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated to the velcro part of the device.The device functioned as designed but was used inappropriately by the (b)(6) year old patient who directly applied the device to her skin.No device malfunction has been identified.This case meets final 10-day eu and 30-day fda reportability.
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