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| Lot Number AP1284 |
| Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
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| Patient Problem
Burn, Thermal (2530)
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| Event Date 12/12/2019 |
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Event Type
Injury
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Event Description
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There were 2, almost 3 burned impression of the heat stones on my back right hip [thermal burn], put a wrap on before bed as i have many a time [device use error].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ap1284, expiration date jan2022, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced burning pain/ burning sensation on an unspecified date, there were 2, almost 3 burned impression of the heat stones on her back right hip on an unspecified date, and skin ripping from the burn wounds on the backside of her right hip on an unspecified date.The patient stated last thursday (unspecified date), she put a wrap on before bed as she has many a time (when needed she has even used them during day time activities and at work).She woke up friday morning (unspecified date) to get dressed for work when she took off the wrap, she had a burning pain on the backside of her right hip.She always sleeps on her left side, never on her right.She was in no pain or discomfort all night.But when she began taking off the wrap she felt an extreme burning sensation and skin ripping from the burn wounds on the backside of her right hip.There were 2, almost 3 burned impression of the heat stones on her back right hip.The stones had shattered for some reason in place, burning a perfectly shaped stone impression burn into her hip.She has been treating them with antibiotic cream and surgical protective wound covers.She is going to have to go to a dermatologist to get professional treatment for these burns.The action taken with thermacare heatwrap was unknown.The 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 of "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 events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "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 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 pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds [burns second degree] , put a wrap on before bed as i have many a time [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ap1284, expiration date jan2022, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced burning pain/ burning sensation on an unspecified date, there were 2, almost 3 burned impression of the heat stones on her back right hip on an unspecified date, and skin ripping from the burn wounds on the backside of her right hip on an unspecified date.The patient stated last thursday (unspecified date), she put a wrap on before bed as she has many a time (when needed she has even used them during day time activities and at work).She woke up friday morning (unspecified date) to get dressed for work when she took off the wrap, she had a burning pain on the backside of her right hip.She always sleeps on her left side, never on her right.She was in no pain or discomfort all night.But when she began taking off the wrap she felt an extreme burning sensation and skin ripping from the burn wounds on the backside of her right hip.There were 2, almost 3 burned impression of the heat stones on her back right hip.The stones had shattered for some reason in place, burning a perfectly shaped stone impression burn into her hip.She has been treating them with antibiotic cream and surgical protective wound covers.She is going to have to go to a dermatologist to get professional treatment for these burns.She was going to the 1st available appointment with her dermatologist's office on 19dec2019 at 8:10 a.M.The action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.Photos of the burns were provided.Additional information has been requested and will be provided as it becomes available.Follow-up (18dec2019): new information received from a contactable consumer via product quality complaint group includes: physician follow-up details (appointment with her dermatologist's office on 19dec2019 at 8:10 a.M) and event information (photos of the burns were provided and the event was updated).Company clinical evaluation comment based on the information provided, the events of "burn blister" and "device use error" 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 events of "burn blistr" and "device use error" 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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Event Description
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Event verbatim [preferred term] burning pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds [burns second degree] , put a wrap on before bed as i have many a time [device use error].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ap1284, expiration date jan2022, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced burning pain/ burning sensation on an unspecified date, there were 2, almost 3 burned impression of the heat stones on her back right hip on an unspecified date, and skin ripping from the burn wounds on the backside of her right hip on an unspecified date.The patient stated last thursday (unspecified date), she put a wrap on before bed as she has many a time (when needed she has even used them during day time activities and at work).She woke up friday morning (unspecified date) to get dressed for work when she took off the wrap, she had a burning pain on the backside of her right hip.She always sleeps on her left side, never on her right.She was in no pain or discomfort all night.But when she began taking off the wrap she felt an extreme burning sensation and skin ripping from the burn wounds on the backside of her right hip.There were 2, almost 3 burned impression of the heat stones on her back right hip.The stones had shattered for some reason in place, burning a perfectly shaped stone impression burn into her hip.She has been treating them with antibiotic cream and surgical protective wound covers.She is going to have to go to a dermatologist to get professional treatment for these burns.She was going to the 1st available appointment with her dermatologist's office on (b)(6) 2019 at 8:10 a.M.The action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.Photos of the burns were provided.Severity of harm was reported as s3.Review of complaint description concludes there is a device malfunction.Site sample status was not received and investigation was still in progress.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(6) 2019: new information received from a contactable consumer via product quality complaint group includes: physician follow-up details (appointment with her dermatologist's office on (b(6) 2019 at 8:10 a.M) and event information (photos of the burns were provided and the event was updated).Follow-up (b)(6) 2019: new information reported from product quality complaints includes severity of harm, malfunction of yes and site sample status not received.Investigation was in progress.Company clinical evaluation comment based on the information provided, the events of "burn blister" and "device use error" 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.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed., comment: based on the information provided, the events of "burn blister" and "device use error" 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.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.
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Manufacturer Narrative
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Ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not be confirmed.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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Event verbatim [preferred term].Put a wrap on before bed as i have many a time/did not check your skin under the product while wearing thermacare (asleep)/read the usage instructions on thermacare before you used the product [intentional device misuse], burning pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds [burns second degree].Narrative: this is a spontaneous report from a contactable consumer.A 70-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ap1284, expiration date jan2022, from (b)(6) 2019 at unknown dose when needed for an unspecified indication.The patient's medical history included ongoing arrhythmia, ongoing atrial fibrillation (afib), had pacemaker on (b)(6) 2014 and post-menopausal.Concomitant medications included sotalol from (b)(6) 2014 and ongoing for arrhythmia, rivaroxaban (xarelto) from (b)(6) 2018 and ongoing for afib.The patient experienced burning pain/ burning sensation, there were 2, almost 3 burned impression of the heat stones on her back right hip, and skin ripping from the burn wounds on the backside of her right hip on (b)(6) 2019.The patient had used thermacare lower back & hip pain wraps since you put the wraps on the market, many years now.The patient stated last thursday ((b)(6) 2019), she put a wrap on before bed as she has many a time (when needed she has even used them during day time activities and at work).She woke up friday morning ((b)(6) 2019) to get dressed for work when she took off the wrap, she had a burning pain on the backside of her right hip.She always sleeps on her left side, never on her right.She was in no pain or discomfort all night.But when she began taking off the wrap she felt an extreme burning sensation and skin ripping from the burn wounds on the backside of her right hip.There were 2, almost 3 burned impression of the heat stones on her back right hip.The stones had shattered for some reason in place, burning a perfectly shaped stone impression burn into her hip.She was not hospitalized due to it.She has been treating them with antibiotic cream and surgical protective wound covers.She is going to have to go to a dermatologist to get professional treatment for these burns.Treatment received for burns included: mineral spirit wipes - to clean burns; (specialty pharmacy name) mepilex border post-op post - surgical adhesive sterile dressings ( 2 dressings per box) 4"x 8" (b)(6) 2019 9boxes (b)(6) per box; neosporin; (b)(6) 2019- silver sulfadiazine 2xday.The patient was currently under the care of a physician for burns.She classified her skin tone as dark or olive.She did not have sensitive skin or abnormal skin conditions.She used the product from (b)(6) 2019 11pm to (b)(6) 2019 9:30 am.She used 10 1/2 hrs per day.She had previously used thermacare when thermacare went retail.She had not experienced the same problem during previous use.She had not previously used other heat products for pain relief.She was sleeping while wearing the product on (b)(6) 2019.She did not engage in exercise while using the product.She did not check your skin under the product while wearing thermacare (asleep).She read the usage instructions on thermacare before you used the product.The action taken with thermacare heatwrap was permanently discontinued on (b)(6) 2019.The outcome of the event burning pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds was not resolved.The outcome of the other event was unknown.Photos of the burns were provided.Severity of harm was reported as s3.Per the product quality group: there was reasonable suggestion of malfunction.Site sample status was not received.Ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not be confirmed.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 (18dec2019): new information received from a contactable consumer via product quality complaint group includes: physician follow-up details (appointment with her dermatologist's office on (b)(6) 2019 at 8:10 a.M) and event information (photos of the burns were provided and the event was updated).Follow-up (27dec2019): new information reported from product quality complaints includes severity of harm, malfunction of yes and site sample status not received.Investigation was in progress.Follow-up (10feb2020): follow-up attempts are completed.No further information is expected.Follow-up (04mar2020): new information reported from product quality complaints includes investigation results.Follow- up (18jun2020): new information received from a contactable consumer included: patient data (age, weight, height), suspect product data (frequency, action taken, stop date), medical history, concomitant medications, past drug history, treatment received, new event (did not check your skin under the product while wearing thermacare (asleep)/read the usage instructions on thermacare before you used the product), event onset date and outcome.
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Manufacturer Narrative
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Ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not be confirmed.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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Event verbatim [preferred term].Burning pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds [burns second degree] , put a wrap on before bed as i have many a time [device use error].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ap1284, expiration date jan2022, from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced burning pain/ burning sensation on an unspecified date, there were 2, almost 3 burned impression of the heat stones on her back right hip on an unspecified date, and skin ripping from the burn wounds on the backside of her right hip on an unspecified date.The patient stated last thursday (unspecified date), she put a wrap on before bed as she has many a time (when needed she has even used them during day time activities and at work).She woke up friday morning (unspecified date) to get dressed for work when she took off the wrap, she had a burning pain on the backside of her right hip.She always sleeps on her left side, never on her right.She was in no pain or discomfort all night.But when she began taking off the wrap she felt an extreme burning sensation and skin ripping from the burn wounds on the backside of her right hip.There were 2, almost 3 burned impression of the heat stones on her back right hip.The stones had shattered for some reason in place, burning a perfectly shaped stone impression burn into her hip.She has been treating them with antibiotic cream and surgical protective wound covers.She is going to have to go to a dermatologist to get professional treatment for these burns.She was going to the 1st available appointment with her dermatologist's office on (b)(6) 2019 at 8:10 a.M.The action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.Photos of the burns were provided.Severity of harm was reported as s3.Per the product quality group: there was reasonable suggestion of malfunction.Site sample status was not received.Ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).The return sample is not available from consumer for evaluation the complaint can not be confirmed.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 (18dec2019): new information received from a contactable consumer via product quality complaint group includes: physician follow-up details (appointment with her dermatologist's office on (b)(6) 2019 at 8:10 a.M) and event information (photos of the burns were provided and the event was updated).Follow-up (27dec2019): new information reported from product quality complaints includes severity of harm, malfunction of yes and site sample status not received.Investigation was in progress.Follow-up (10feb2020): follow-up attempts are completed.No further information is expected.Follow-up (04mar2020): new information reported from product quality complaints includes investigation results.Comment: based on the information provided, the events of "burn blister" and "device use error" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.Returned sample is not available, complaint cannot be confirmed.No further investigations or actions is suggested at this time.
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Event Description
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Event verbatim [preferred term] put a wrap on before bed as i have many a time/did not check your skin under the product while wearing thermacare (asleep)/read the usage instructions on thermacare before you used the product [intentional device misuse], burning pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds [burns second degree], the stones had shattered for some reason in place [device issue], , narrative: this is a spontaneous report from a contactable consumer.A 70-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ap1284, expiration date jan2022, from 12dec2019 at unknown dose when needed for an unspecified indication.The patient's medical history included ongoing arrhythmia, ongoing atrial fibrillation (afib), had pacemaker on (b)(6) 2014 and post-menopausal.Concomitant medications included sotalol from (b)(6) 2014 and ongoing for arrhythmia, rivaroxaban (xarelto) from jul2018 and ongoing for afib.The patient experienced burning pain/ burning sensation, there were 2, almost 3 burned impression of the heat stones on her back right hip, and skin ripping from the burn wounds on the backside of her right hip on (b)(6) 2019.The patient had used thermacare lower back & hip pain wraps since you put the wraps on the market, many years now.The patient stated last thursday ((b)(6) 2019), she put a wrap on before bed as she has many a time (when needed she has even used them during day time activities and at work).She woke up friday morning ((b)(6) 2019) to get dressed for work when she took off the wrap, she had a burning pain on the backside of her right hip.She always sleeps on her left side, never on her right.She was in no pain or discomfort all night.But when she began taking off the wrap she felt an extreme burning sensation and skin ripping from the burn wounds on the backside of her right hip.There were 2, almost 3 burned impression of the heat stones on her back right hip.The stones had shattered for some reason in place, burning a perfectly shaped stone impression burn into her hip on (b)(6) 2019.She was not hospitalized due to it.She has been treating them with antibiotic cream and surgical protective wound covers.She was going to have to go to a dermatologist to get professional treatment for these burns.Treatment received for burns included: mineral spirit wipes - to clean burns; (specialty pharmacy name) mepilex border post-op post - surgical adessive sterile dressings ( 2 dressings per box) 4"x 8" 1 (b)(6) 2019 90 boxes $ 14.49 per box; neosporin; silver sulfadiazine 2xday.The patient was currently under the care of a physician for burns.She classified her skin tone as dark or olive.She did not have sensitive skin or abnormal skin conditions.She used the product from 12dec2019 11pm to 13dec2019 9:30 am.She used 10 1/2 hrs per day.She had previously used thermacare when thermacare went retail.She had not experienced the same problem during previous use.She had not previously used other heat products for pain relief.She was sleeping while wearing the product on 12dec2019.She did not engage in exercise while using the product.She did not check your skin under the product while wearing thermacare (asleep).She read the usage instructions on thermacare before you used the product.The action taken with thermacare heatwrap was permanently discontinued on 13dec2019.The outcome of the event burning pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds and the stones had shattered for some reason in place was not resolved.The outcome of the other event was unknown.Photos of the burns were provided.Per the product quality group: site sample has been received at the site on 08jan2020.Return sample evaluation: one lbh pouch; pouch is open.(l) ap1284.Exp jan2022.Complaint sub-class: heat cells damaged/leaking.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.Summary of investigation: ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the consumer returned sample does not provide any additional evidence as to why the consumer stated "the stones had shattered for some reason in place".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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking received at the (site name withheld) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 2 was below the upper control limit (ucl) of 25.2 complaints per sop-#, complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.Based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 36 month trend chart attached lbh heat cell damaged leaking 15dec2016 to 15-12-15-17 to 15dec2019.This investigation was reopened on 07oct2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.Complaint sub-class: adverse event/serious/unknown.Summary of investigation: ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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, "patient experienced burning pain/ burning sensation on an unspecified date, there were 2, almost 3 burned impression of the heat stones on her back right hip on an unspecified date, and skin ripping from the burn wounds on the backside of her right hip on an unspecified date".The cause of the consumer stating the wraps were causing burn marks is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Evaluation of the consumer returned sample did not provide any additional evidence of why the consumer experienced an adverse event while wearing a wrap.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the a trend does not exist for this batch.Fifth complaint for the sub class adverse event/serious/unknown received at the (site name) site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing root cause related to the subclass.Per sop-#, complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified for the lot and subclass.Refer to the attachment adverse event serious-unknown ap1284.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 36 month trend chart attached lbh ae serious unknown 15dec2016 to15dec2019.This investigation was reopened on 07oct2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.Follow-up (18dec2019): new information received from a contactable consumer via product quality complaint group includes: physician follow-up details (appointment with her dermatologist's office on 19dec2019 at 8:10 a.M) and event information (photos of the burns were provided and the event was updated).Follow-up (27dec2019): new information reported from product quality complaints includes severity of harm, malfunction of yes and site sample status not received.Investigation was in progress.Follow-up (10feb2020): follow-up attempts are completed.No further information is expected.Follow-up (04mar2020): new information reported from product quality complaints includes investigation results.Follow- up (18jun2020): new information received from a contactable consumer included: patient data (age, weight, height), suspect product data (frequency, action taken, stop date), medical history, concomitant medications, past drug history, treatment received, new event (did not check your skin under the product while wearing thermacare (asleep)/read the usage instructions on thermacare before you used the product), event onset date and outcome.Follow-up (02sep2020 and 02sep2020): new information received from product quality complaint group includes updated investigation results.This follow-up is also submitted to amend previously reported information: new event "the stones had shattered for some reason in place" added.Follow-up attempts are completed.No further information is expected.Follow-up (09oct2020 and 09oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Site sample has been received at the site on 08jan2020.Return sample evaluation: one lbh pouch; pouch is open.(l) ap1284.Exp jan2022.Complaint sub-class: heat cells damaged/leaking.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.Summary of investigation: ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the consumer returned sample does not provide any additional evidence as to why the consumer stated "the stones had shattered for some reason in place".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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking received at the (site name withheld) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 2 was below the upper control limit (ucl) of 25.2 complaints per sop-#, complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.Based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 36 month trend chart attached lbh heat cell damaged leaking 15dec2016 to 15-12-15-17 to 15dec2019.This investigation was reopened on 07oct2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.Complaint sub-class: adverse event/serious/unknown.Summary of investigation: ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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, "patient experienced burning pain/ burning sensation on an unspecified date, there were 2, almost 3 burned impression of the heat stones on her back right hip on an unspecified date, and skin ripping from the burn wounds on the backside of her right hip on an unspecified date".The cause of the consumer stating the wraps were causing burn marks is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Evaluation of the consumer returned sample did not provide any additional evidence of why the consumer experienced an adverse event while wearing a wrap.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the a trend does not exist for this batch.Fifth complaint for the sub class adverse event/serious/unknown received at the (site name) site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing root cause related to the subclass.Per sop-#, complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified for the lot and subclass.Refer to the attachment adverse event serious-unknown ap1284.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 36 month trend chart attached lbh ae serious unknown 15dec2016 to15dec2019.This investigation was reopened on 07oct2020 to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from sop-#, complaint trending guidelines, effective dates 19nov2019 and 24feb2020.A notification of nonconformance was opened pr-#.This deviation will not change the conclusion of the investigation.
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Event Description
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Event verbatim [preferred term], put a wrap on before bed as i have many a time/did not check your skin under the product while wearing thermacare (asleep)/read the usage instructions on thermacare before you used the product [intentional device misuse], burning pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds [burns second degree], the stones had shattered for some reason in place [device issue].Narrative: this is a spontaneous report from a contactable consumer.A 70-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number ap1284, expiration date jan2022, from (b)(6) 2019 at unknown dose when needed for an unspecified indication.The patient's medical history included ongoing arrhythmia, ongoing atrial fibrillation (afib), had pacemaker on (b)(6) 2014 and post-menopausal.Concomitant medications included sotalol from (b)(6) 2014 and ongoing for arrhythmia, rivaroxaban (xarelto) from (b)(6)2018 and ongoing for afib.The patient experienced burning pain/ burning sensation, there were 2, almost 3 burned impression of the heat stones on her back right hip, and skin ripping from the burn wounds on the backside of her right hip on (b)(6) 2019.The patient had used thermacare lower back & hip pain wraps since you put the wraps on the market, many years now.The patient stated last thursday ((b)(6) 2019), she put a wrap on before bed as she has many a time (when needed she has even used them during day time activities and at work).She woke up friday morning ((b)(6) 2019) to get dressed for work when she took off the wrap, she had a burning pain on the backside of her right hip.She always sleeps on her left side, never on her right.She was in no pain or discomfort all night.But when she began taking off the wrap she felt an extreme burning sensation and skin ripping from the burn wounds on the backside of her right hip.There were 2, almost 3 burned impression of the heat stones on her back right hip.The stones had shattered for some reason in place, burning a perfectly shaped stone impression burn into her hip on (b)(6) 2019.She was not hospitalized due to it.She has been treating them with antibiotic cream and surgical protective wound covers.She was going to have to go to a dermatologist to get professional treatment for these burns.Treatment received for burns included: mineral spirit wipes - to clean burns; (specialty pharmacy name) mepilex border post-op post - surgical adessive sterile dressings ( 2 dressings per box) 4"x 8" (b)(6) 2019-(b)(6) 2019 9boxes $ 14.49 per box; neosporin; (b)(6) 2019- silver sulfadiazine 2xday.The patient was currently under the care of a physician for burns.She classified her skin tone as dark or olive.She did not have sensitive skin or abnormal skin conditions.She used the product from (b)(6) 2019 11pm to (b)(6) 2019 9:30 am.She used 10 1/2 hrs per day.She had previously used thermacare when thermacare went retail.She had not experienced the same problem during previous use.She had not previously used other heat products for pain relief.She was sleeping while wearing the product on (b)(6) 2019.She did not engage in exercise while using the product.She did not check your skin under the product while wearing thermacare (asleep).She read the usage instructions on thermacare before you used the product.The action taken with thermacare heatwrap was permanently discontinued on (b)(6) 2019.The outcome of the event burning pain/ burning sensation/there were 2, almost 3 burned impression of the heat stones on her back right hip/ felt an extreme burning sensation and skin ripping from the burn wounds and the stones had shattered for some reason in place was not resolved.The outcome of the other event was unknown.Photos of the burns were provided.Per the product quality group: severity of harm was reported as s3.There was reasonable suggestion of malfunction.Site sample has been received at the site on 08jan2020.Return sample evaluation: one lbh pouch; pouch is open.(l) ap1284.Exp jan2022.Complaint sub-class: heat cells damaged/leaking.Summary of investigation: ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the consumer returned sample does not provide any additional evidence as to why the consumer stated "the stones had shattered for some reason in place".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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking received at the (site name withheld) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 2 was below the upper control limit (ucl) of (b)(4) complaints per (b)(4), complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 24 month trend chart attached heat cell damaged-leaking lbh (b)(6) 2017 to (b)(6) 2019.Complaint sub-class: adverse event/serious/unknown.Investigation findings: ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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, "patient experienced burning pain/ burning sensation on an unspecified date, there were 2, almost 3 burned impression of the heat stones on her back right hip on an unspecified date, and skin ripping from the burn wounds on the backside of her right hip on an unspecified date".The cause of the consumer stating the wraps were causing burn marks is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Evaluation of the consumer returned sample did not provide any additional evidence of why the consumer experienced an adverse event while wearing a wrap.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event/serious/unknown received at the (site name withheld) site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing root cause related to the subclass.Per (b)(4), complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified for the lot and subclass.Refer to the attachment adverse event serious-unknown ap1284.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 24 month trend chart attached adverse event lbh (b)(4) 2017 to (b)(4) 2019.Follow-up (18dec2019): new information received from a contactable consumer via product quality complaint group includes: physician follow-up details (appointment with her dermatologist's office on (b)(6) 2019 at 8:10 a.M) and event information (photos of the burns were provided and the event was updated).Follow-up (27dec2019): new information reported from product quality complaints includes severity of harm, malfunction of yes and site sample status not received.Investigation was in progress.Follow-up (10feb2020): follow-up attempts are completed.No further information is expected.Follow-up (04mar2020): new information reported from product quality complaints includes investigation results.Follow- up (18jun2020): new information received from a contactable consumer included: patient data (age, weight, height), suspect product data (frequency, action taken, stop date), medical history, concomitant medications, past drug history, treatment received, new event (did not check your skin under the product while wearing thermacare (asleep)/read the usage instructions on thermacare before you used the product), event onset date and outcome.Follow-up (02sep2020 and 02sep2020): new information received from product quality complaint group includes updated investigation results.This follow-up is also submitted to amend previously reported information: new event "the stones had shattered for some reason in place" added.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Severity of harm was reported as s3.There was reasonable suggestion of malfunction.Site sample has been received at the site on 08jan2020.Return sample evaluation: one lbh pouch; pouch is open.(l) ap1284.Exp jan2022.Complaint sub-class: heat cells damaged/leaking.Summary of investigation: ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the consumer returned sample does not provide any additional evidence as to why the consumer stated "the stones had shattered for some reason in place".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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class cells damaged/leaking received at the (site name withheld) site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 2 was below the upper control limit (ucl) of (b)(4) complaints per (b)(4), complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass.Based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 24 month trend chart attached heat cell damaged-leaking lbh (b)(6) 2017 to (b)(6) 2019.Complaint sub-class: adverse event/serious/unknown.Investigation findings: ap1284 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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, "patient experienced burning pain/ burning sensation on an unspecified date, there were 2, almost 3 burned impression of the heat stones on her back right hip on an unspecified date, and skin ripping from the burn wounds on the backside of her right hip on an unspecified date".The cause of the consumer stating the wraps were causing burn marks is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Evaluation of the consumer returned sample did not provide any additional evidence of why the consumer experienced an adverse event while wearing a wrap.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event/serious/unknown received at the (site name withheld) site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing root cause related to the subclass.Per (b)(4), complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified for the lot and subclass.Refer to the attachment adverse event serious-unknown ap1284.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 24 month trend chart attached adverse event lbh (b)(6) 2017 to (b)(6) 2019.
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Search Alerts/Recalls
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