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| Lot Number S68511 |
| Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Burning Sensation (2146); Tingling (2171); Burn, Thermal (2530); Patient Problem/Medical Problem (2688)
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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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Event verbatim [preferred term] burning on my neck and my shoulder/ burning sensation/ tingling/ skin was burnt [thermal burn] , did not check her skin under the product while wearing thermacare [device use error] , using for pinched nerves in shoulder [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist, device lot number s68511, expiration date apr2020), topically directly on the skin on (b)(6) 2018 for pinched nerves in shoulder.Medical history included blood pressure and back injury.The patient is currently under the care of a physician for back injury and pinched nerves.Concomitant medication included paracetamol (tylenol [paracetamol]) and amlodipine (amlodipine).On (b)(6) 2018, the patient applied the heatwrap at approximately 9:30am and went to see her doctor for her annual.Approximately 2 hours later as she was leaving the doctor's office she felt a burning sensation and it was like some skin had burnt, some dryness, and she had to take thermacare off.The patient felt burning on neck and shoulder and when she got home, she looked and put some cortisone cream on it.The patient continues to experience a little tingling.During the patient's visit to back specialist on (b)(6) 2018, the patient showed the doctor the burn, who recommended the patient report the event.No additional treatment was provided.The patient classified skin tone as medium, has sensitive skin, but no abnormal skin conditions.The patient has previously used thermacare, but never got burned before.The patient has not previously used other heat products for pain relief.The patient was not sleeping while wearing the product.The patient was wearing regular clothes, shirt over the heatwrap directly on her skin and had read the usage instructions on thermacare before using the product.She did not check her skin under the product while wearing thermacare.The patient has the product remaining.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of burn was not recovered.The outcome of the other 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 of thermal burn and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use issue is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of thermal burn and device use error as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use issue is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] burning on my neck and my shoulder/ burning sensation/ tingling/ skin was burnt/ burn to posterior neck [thermal burn] , heatwrap directly on her skin/did not check her skin under the product while wearing thermacare/had read the usage instructions on thermacare before using the product [intentional device misuse] , pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored [scar] , pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored [keloid scar] , using for pinched nerves in shoulder [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer, and later from a contactable nurse.A 57-year-old female patient (weight: 149 lb, height 157cm) started to receive thermacare heatwrap (thermacare neck, shoulder & wrist, device lot number s68511, expiration date apr2020), topically directly on the skin on (b)(6) 2018 for pinched nerves in shoulder.Medical history included blood pressure and back injury.The patient is currently under the care of a physician for back injury and pinched nerves.Patient had no prior medical history, no relevant drug history, and no history of drug or alcohol abuse.It was reported that "drug allergies: no.(if yes, please specify): keflex, ibuprofen, tramadol".Concomitant medication included paracetamol (tylenol [paracetamol]) and amlodipine.Nurse reported that the patient wasn't on any relevant medications, including topical medications, at the time of the adverse events.On (b)(6) 2018, the patient applied the heatwrap at approximately 9:30am and went to see her doctor for her annual.Approximately 2 hours later as she was leaving the doctor's office she felt a burning sensation and it was like some skin had burnt, some dryness, and she had to take thermacare off.The patient felt burning on neck and shoulder and when she got home, she looked and put some cortisone cream on it.The patient continues to experience a little tingling.During the patient's visit to back specialist on (b)(6) 2018, the patient showed the doctor the burn, who recommended the patient report the event.No additional treatment was provided.The patient classified skin tone as medium, has sensitive skin, but no abnormal skin conditions.The patient has previously used thermacare, but never got burned before.The patient has not previously used other heat products for pain relief.The patient was not sleeping while wearing the product.The patient was wearing regular clothes, shirt over the heatwrap directly on her skin and had read the usage instructions on thermacare before using the product.She did not check her skin under the product while wearing thermacare.The patient has the product remaining.Later, a nurse reported that the patient did not provide information regarding the reported adverse event(s) with the use of the product; however, it was considered that the pfizer product had a causal effect to the adverse event and that it was related to suspect device.Patient was not admitted to hospital for "burn to posterior neck", however treatment was required which was ointment applied by the patient, as the patient had a scar at burn site/scarred area at burn site.No specific tests were required, and no surgical intervention, such as debridement, was required.The nurse reported that it was expected the patient to experience long-term sequelae such as scarring, "scarring present in appearance of keloid development area is raised and discolored." the action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event burn was recovered on (b)(6) 2018 with sequelae.The outcome of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (26dec2018): this is a follow-up spontaneous report from a contactable nurse includes: patient's information (age, height, and weight), and that the patient did not provide information regarding the reported adverse event, causality, no prior medical history, no relevant drug history, and no history of drug or alcohol abuse, "drug allergies: no (if yes, please specify): keflex, ibuprofen, tramadol", no hospital admission for "burn to posterior neck", new event "pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored", treatment information, updated outcome (from not recovered to recovered with sequelae with date), no specific tests, no surgical intervention, no relevant medications, and expectation of long-term sequelae.Updated event coding of previously reported events "did not check her skin under the product while wearing thermacare" from device use error to intentional device misuse and "using for pinched nerves in shoulder" from device use issue to intentional device use for unlabeled indication.Company clinical evaluation comment: based on the information provided, the events of thermal burn, intentional device misuse, scar, and keloid scar as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of thermal burn, intentional device misuse, scar, and keloid scar as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is 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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Investigation summary: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per spec-25353, effective: date: 28nov2016.Consumer reports "thermacare has burnt me" from a wrap.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.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 product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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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Burning on my neck and my shoulder/ burning sensation/ tingling/ skin was burnt/ burn to posterior neck [thermal burn], did not check her skin under the product while wearing thermacare/had read the usage instructions on thermacare before using the product [intentional device misuse], pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored [scar], pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored [keloid scar], using for pinched nerves in shoulder [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer and a contactable nurse.A 57-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist, device lot number s68511, expiration date apr2020), topically directly on the skin on (b)(6) 2018 9:30am for pinched nerves in shoulder.Medical history included sensitive skin, blood pressure abnormal and back injury.The patient was currently under the care of a physician for back injury and pinched nerves.Patient had no history of drug or alcohol abuse.Concomitant medication included paracetamol (tylenol) and amlodipine for blood pressure.The patient previously took cefalexin monohydrate (keflex), ibuprofen, tramadol and experienced drug allergies.The patient had previously used thermacare heatwraps, but never got burned before.The patient had not previously used other heat products for pain relief.On (b)(6) 2018, the patient applied the heatwrap at approximately 9:30am and went to see her doctor for her annual.Approximately 2 hours later ((b)(6) 2018 11:30am) as she was leaving the doctor's office she felt a burning sensation and it was like some skin had burnt, some dryness, and she had to take thermacare off.The patient felt burning on neck and shoulder and when she got home, she looked and put some cortisone cream on it.The patient continued to experience a little tingling.During the patient's visit to back specialist on (b)(6) 2018, the patient showed the doctor the burn, who recommended the patient report the event.No additional treatment was provided.Her doctor called her and indicated that she was aware of a recall where the wraps were leaking, but the patient stated the wrap that burned her was not leaking nor had any black/charcoal residue on the wrap.The patient classified skin tone as medium, had sensitive skin, but no abnormal skin conditions.The patient was not sleeping while wearing the product.The patient was wearing regular clothes, shirt over the heatwrap directly on her skin and had read the usage instructions on thermacare before using the product.She did not check her skin under the product while wearing thermacare on (b)(6) 2018.The patient had the product remaining.A nurse further reported that the patient did provide information regarding the reported adverse events with the use of the product; however it was considered that the pfizer product had a causal effect to the adverse event and that it was related to suspect device.Patient was not admitted to hospital for "burn to posterior neck", however treatment was required which was ointment applied by the patient, as the patient had a scar at burn site/scarred area at burn site in 2018.No specific tests were required, and no surgical intervention, such as debridement, was required.The nurse reported that it was expected the patient to experience long-term sequelae such as scarring, "scarring present in appearance of keloid development area is raised and discolored" in 2018.Device was available for evaluation.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event burn was recovered with sequelae on (b)(6) 2018.The outcome of the other events was unknown.As of 03jan2019, according to the product quality complaint group: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per spec-25353, effective: date: 28nov2016.Consumer reports "thermacare has burnt me" from a wrap.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.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 product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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 (26dec2018): this is a follow-up spontaneous report from a contactable nurse includes: patient's information (age, height, and weight), and that the patient did not provide information regarding the reported adverse event, causality, no history of drug or alcohol abuse, "drug allergies: keflex, ibuprofen, tramadol", no hospital admission for "burn to posterior neck", new event "pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored", treatment information, updated outcome (from not recovered to recovered with sequelae with date), no specific tests, no surgical intervention, and expectation of long-term sequelae.Updated event coding of previously reported events "did not check her skin under the product while wearing thermacare" from device use error to intentional device misuse and "using for pinched nerves in shoulder" from device use issue to intentional device use for unlabeled indication.Follow-up (03jan2019): this is a follow-up report received from the product quality complaint group includes investigational results, medical history sensitive skin added and onset date of events updated.Follow-up (16jan2019): new information received from a contactable nurse included: the patient did provide information regarding the reported adverse event.Follow up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of thermal burn, intentional device misuse, scar, and keloid scar as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.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 thermal burn, intentional device misuse, scar, and keloid scar as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.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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Event Description
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Burning on my neck and my shoulder/ burning sensation/ tingling/ skin was burnt/ burn to posterior neck [thermal burn], did not check her skin under the product while wearing thermacare/had read the usage instructions on thermacare before using the product [intentional device misuse], pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored [scar], pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored [keloid scar], using for pinched nerves in shoulder [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer and a contactable nurse.A 57-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist, device lot number: s68511, expiration date: apr2020), topically directly on the skin on (b)(6) 2018 9:30am for pinched nerves in shoulder.Medical history included sensitive skin, blood pressure abnormal and back injury.The patient was currently under the care of a physician for back injury and pinched nerves.Patient had no history of drug or alcohol abuse.Concomitant medication included paracetamol (tylenol) and amlodipine for blood pressure.The patient previously took cefalexin monohydrate (keflex), ibuprofen, tramadol and experienced drug allergies.The patient had previously used thermacare heatwraps, but never got burned before.The patient had not previously used other heat products for pain relief.On (b)(6) 2018, the patient applied the heatwrap at approximately 9:30am and went to see her doctor for her annual.Approximately 2 hours later (on (b)(6) 2018 11:30am) as she was leaving the doctor's office she felt a burning sensation and it was like some skin had burnt, some dryness, and she had to take thermacare off.The patient felt burning on neck and shoulder and when she got home, she looked and put some cortisone cream on it.The patient continued to experience a little tingling.During the patient's visit to back specialist on (b)(6) 2018, the patient showed the doctor the burn, who recommended the patient report the event.No additional treatment was provided.Her doctor called her and indicated that she was aware of a recall where the wraps were leaking, but the patient stated the wrap that burned her was not leaking nor had any black/charcoal residue on the wrap.The patient classified skin tone as medium, had sensitive skin, but no abnormal skin conditions.The patient was not sleeping while wearing the product.The patient was wearing regular clothes, shirt over the heatwrap directly on her skin and had read the usage instructions on thermacare before using the product.She did not check her skin under the product while wearing thermacare on (b)(6) 2018.The patient had the product remaining.A nurse further reported that the patient did not provide information regarding the reported adverse events with the use of the product; however it was considered that the pfizer product had a causal effect to the adverse event and that it was related to suspect device.Patient was not admitted to hospital for "burn to posterior neck", however treatment was required which was ointment applied by the patient, as the patient had a scar at burn site/scarred area at burn site in 2018.No specific tests were required, and no surgical intervention, such as debridement, was required.The nurse reported that it was expected the patient to experience long-term sequelae such as scarring, "scarring present in appearance of keloid development area is raised and discolored" in 2018.Device was available for evaluation.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the event burn was recovered with sequelae on (b)(6) 2018.The outcome of the other events was unknown.As of on (b)(6) 2019, according to the product quality complaint group: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per spec-25353, effective: date: 28nov2016.Consumer reports "thermacare has burnt me" from a wrap.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.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 product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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 (26dec2018): this is a follow-up spontaneous report from a contactable nurse includes: patient's information (age, height, and weight), and that the patient did not provide information regarding the reported adverse event, causality, no history of drug or alcohol abuse, "drug allergies: keflex, ibuprofen, tramadol", no hospital admission for "burn to posterior neck", new event "pt has scarred area at burn site/scarring present in appearance of keloid development area is raised and discolored", treatment information, updated outcome (from not recovered to recovered with sequelae with date), no specific tests, no surgical intervention, and expectation of long-term sequelae.Updated event coding of previously reported events "did not check her skin under the product while wearing thermacare" from device use error to intentional device misuse and "using for pinched nerves in shoulder" from device use issue to intentional device use for unlabeled indication.Follow-up (03jan2019): this is a follow-up report received from the product quality complaint group includes investigational results, medical history sensitive skin added and onset date of events updated.Company clinical evaluation comment: based on the information provided, the events of thermal burn, intentional device misuse, scar, and keloid scar as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.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 thermal burn, intentional device misuse, scar, and keloid scar as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.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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Manufacturer Narrative
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Investigation summary: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per spec-25353, effective: date: 28nov2016.Consumer reports "thermacare has burnt me" from a wrap.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.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 product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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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