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| Lot Number H43487 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] expiration date: 18oct2016.Consumer was (b)(6) when he used it [expired device used], he also used it on his neck/works on other places of his body [device use issue] , they last way longer than 12 hours [device issue], after he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day [device use error].Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) male consumer started to receive thermacare heatwrap (thermacare knee & elbow) lot number h43487, expiration date 18oct2016, udi number (b)(4), from unknown date for neck and back hurt.Medical history and concomitant medications were none.Consumer used thermacare knee and elbow heatwrap.They expired 18oct2016.He also used it on his neck.He stated how great they work and they work for other places on his body.The transfer agent told him not to use after expiration or to use other places besides knee and elbow.Consumer clarified not expired date but its probably dated for when it was purchased.He got it at (company name).He had two more in the box and they last way longer than 12 hours.It lasted for two days.After he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day.He used it twice after using it on his neck he put it in a plastic bag and used it the next day.Consumer was (b)(6) when he used it.It had been sitting on the cupboard for a long time.He bought it for his daughter and it was too hot for her.He used at least a year after he bought it or it could have been two.He had stopped using it.He used it for two different days.It had 12 hours of heat.He placed it in a sealed bag.It helped a lot with his neck and lower back.It helped on two different days.He used an ace bandage to keep in place.It helped really good.He bought it because his neck and back hurt.It worked great.He could send it back.Ultra thin, discrete, and odorless, and comfortable were on there.There were a lot of papers.There were three different products.It had directions on the box.It said ask the doctor before use.Consumer reported he never asked the doctor.He had a little trouble opening up the booklet inside.It said fifty five or older has increased risk of burning.He clarified that his daughter didn't use the product.She never used the product, she just said she cant use it.The action taken in response to the event of the product was permanently discontinued.The outcome of the event was unknown.Consumer thought there was not a reasonable possibility that an ae(s) is related to the device.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error" "device use issue" and "expired device use" are non-serious.The events were assessed as associated with the use of the device., comment: based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error" "device use issue" and "expired device use" are non-serious.The events were assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] expiration date 18oct2016/consumer was 67 years old when he used it [expired device used] , he also used it on his neck/works on other places of his body [device use issue] , they last way longer than 12 hours [device issue] , after he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day [device use error].Case narrative:this is a spontaneous report from a contactable consumer.This 67-years-old male consumer started to receive thermacare heatwrap (thermacare knee & elbow) lot number h43487, expiration date 18oct2016, udi number (b)(4), from unknown date for neck and back hurt.Medical history and concomitant medications were none.Consumer used thermacare knee and elbow heatwrap.They expired 18oct2016.He also used it on his neck.He stated how great they work and they work for other places on his body.The transfer agent told him not to use after expiration or to use other places besides knee and elbow.Consumer clarified not expired date but its probably dated for when it was purchased.He had two more in the box and they last way longer than 12 hours.It lasted for two days.After he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day.He used it twice after using it on his neck he put it in a plastic bag and used it the next day.Consumer was 67 years old when he used it.It had been sitting on the cupboard for a long time.He used at least a year after he bought it or it could have been two.He had stopped using it.He used it for two different days.It had 12 hours of heat.He placed it in a sealed bag.It helped a lot with his neck and lower back.It helped on two different days.He used an ace bandage to keep in place.It helped really good.He bought it because his neck and back hurt.It worked great.Device was available for evaluation.He could send it back.Ultra thin, discrete, and odorless, and comfortable were on there.There were a lot of papers.There were three different products.It had directions on the box.It said ask the doctor before use.Consumer reported he never asked the doctor.He had a little trouble opening up the booklet inside.It said fifty five or older has increased risk of burning.The action taken in response to the events of the product was permanently discontinued.The outcome of the events was unknown.Consumer thought there was not a reasonable possibility that an ae is related to the device.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: medical history updated.Company clinical evaluation comment based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error" "device use issue" and "expired device use" are non-serious.The events were assessed as associated with the use of the device., comment: based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error" "device use issue" and "expired device use" are non-serious.The events were assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] they last way longer than 12 hours/it lasted for two days [device issue] , expiration date 18oct2016/consumer was 67 years old when he used it [expired device used] , he also used it on his neck/works on other places of his body [device use issue] , after he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day [device use error].Case narrative:this is a spontaneous report from a contactable consumer.This 67-year-old male consumer started to receive thermacare heatwrap (thermacare knee & elbow) lot number h43487, expiration date 31aug2016 (reported as (b)(6) 2016 by consumer), udi number (b)(4), from unknown date for his neck and back hurt.Also provided for one inside the box has "lot number h47687.It is different.Expiration: aug2016 01:14.Sep2021" medical history and concomitant medications were none.He bought it for his daughter, but didn't use the product.The consumer used thermacare heatwrap, and they expired on 18oct2016.He also used it on his neck.He stated how great they work and they work for other places on his body.The consumer clarified "not expired date but its probably dated for when it was purchased." they last way longer than 12 hours.It lasted for two days.After he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day.He used it twice after using it on his neck he put it in a plastic bag and used it the next day.It had been sitting on the cupboard for a long time.He used at least a year after he bought it or it could have been two.He had stopped using it.He used it and helped on two different days.It had 12 hours of heat.He placed it in a sealed bag.It helped a lot with his neck and lower back.He used an ace bandage to keep in place.It helped really good.It worked great."ultra thin, discrete, and odorless, and comfortable were on there.There were a lot of papers.There were three different products." it had directions on the box.It said ask the doctor before use.Consumer reported he never asked the doctor.He had a little trouble opening up the booklet inside.It said fifty five or older has increased risk of burning.Packaging was sealed and intact.Device was available for evaluation, and he could send it back.Product count size dispensed: 3 pack; still has 2 of them.The action taken with the product was permanently discontinued.The outcome of the events was unknown.Consumer thought there was not a reasonable possibility that an ae is related to the device.According to the product quality complaint group: severity of harm: s3 for complaint sub-class: adverse event/serious/unknown.An investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced the product being too hot to use.No burn injury was reported.And permanently discontinued use of product.Additional information received from product quality complaint group: manufacturing site assessment: 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 used expired product.Consumer did not report an adverse event occurring.Review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the manufacturing site requiring an evaluation for this lot.The previous investigation were not confirmed to have a manufacturing root cause related to the subclass.Per complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify if a potential trend exist for the lot and subclass.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assessment & 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.Return sample evaluation: a return sample has not been received at the site.Also provided investigation on class/subclass: non-defect / personal preference | non-defect/ personal preference not classified.Cass/subclass: external cause investigation / adverse event/negligible-minor.Class/subclass: external cause ivestigation/adverse event/serious/unknown.Reasonably suggests no device malfunction with severity of harm ranking n/a.Capa previously identified and but no capas in place.No full investigation required.Qa review & rationale, summary of investigation, conclusion, and document review summary: refer to evaluation of complaints related to non-defect.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.No reserve sample evaluation and test required.No lot-specific trend and expedite trend were identified.Site sample status: not received.Sterile product: no.Evaluation of complaints related to non-defect subclass: introduction: thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (city name) site is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where there is no quality defect.A non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and close with no further action taken.Amendment: this follow-up report is being submitted to amend previously reported information: medical history updated.Follow up (27nov2019): new information received from the product quality complaint group includes severity rating, malfunction assessment and case upgraded to serious, reportable mdr.Follow-up (02dec2019): new information received from product quality complaint group includes investigation results.Follow-up (16dec2019): new information received from the product quality complaint group included: additional lot number and expiration date, updated expiration for lot number h43487 (from 18oct2016 to 31aug2016), additional complaint class and subclass and it's investigations including summary of investigation conclusion and other investigation findings, evaluation of complaints related to non-defect, sample status.Company clinical evaluation comment: based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error", "device use issue" and "expired device use" are non-serious.The events were 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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on available information, the patient reported "they last way longer than 12 hours/ it lasted for two days" (device issue) which represents a potential device malfunction is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error", "device use issue" and "expired device use" are non-serious.The events were 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.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Severity of harm: s3 for complaint sub-class: adverse event/serious/unknown.An investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced the product being too hot to use.No burn injury was reported.And permanently discontinued use of product.Additional information received from product quality complaint group: manufacturing site assessment: 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 used expired product.Consumer did not report an adverse event occurring.Review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the manufacturing site requiring an evaluation for this lot.The previous investigation were not confirmed to have a manufacturing root cause related to the subclass.Per complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify if a potential trend exist for the lot and subclass.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assessment & ra.
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Manufacturer Narrative
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Manufacturing site assessment: 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 used expired product.Consumer did not report an adverse event occurring.Review of records does not provide evidence to support defective product.Care should be the product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.The previous investigation were not confirmed to have a manufacturing root cause related to the subclass.Per sop-(b)(4), complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify if a potential trend exist for the lot and subclass.No trend was identified.Refer to attachment adverse event serious unknown h43487.On the basis of this evaluation, a trend does not exist for this lot.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.Return sample evaluation: a return sample has not been received at the site.
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Event Description
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Event verbatim [preferred term] they last way longer than 12 hours/it lasted for two days [device issue] , expiration date 18oct2016/consumer was 67 years old when he used it [expired device used] , he also used it on his neck/works on other places of his body [device use issue] , after he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 67-year-old male consumer started to receive thermacare heatwrap (thermacare knee & elbow) lot number h43487, expiration date 18oct2016, udi number (b)(4), from unknown date for neck and back hurt.Medical history and concomitant medications were none.Consumer used thermacare knee and elbow heatwrap.They expired on 18oct2016.He also used it on his neck.He stated how great they work and they work for other places on his body.The transfer agent told him not to use after expiration or to use other places besides knee and elbow.Consumer clarified not expired date but its probably dated for when it was purchased.He had two more in the box and they last way longer than 12 hours.It lasted for two days.After he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day.He used it twice after using it on his neck he put it in a plastic bag and used it the next day.Consumer was 67 years old when he used it.It had been sitting on the cupboard for a long time.He used at least a year after he bought it or it could have been two.He had stopped using it.He used it for two different days.It had 12 hours of heat.He placed it in a sealed bag.It helped a lot with his neck and lower back.It helped on two different days.He used an ace bandage to keep in place.It helped really good.He bought it because his neck and back hurt.It worked great.Device was available for evaluation.He could send it back.Ultra thin, discrete, and odorless, and comfortable were on there.There were a lot of papers.There were three different products.It had directions on the box.It said ask the doctor before use.Consumer reported he never asked the doctor.He had a little trouble opening up the booklet inside.It said fifty five or older has increased risk of burning.The action taken in response to the events of the product was permanently discontinued.The outcome of the events was unknown.Consumer thought there was not a reasonable possibility that an ae is related to the device.According to the product quality complaint group: dchu assessment: severity of harm: s3 for complaint sub-class: adverse event/serious/unknown.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced the product being too hot to use no burn injury was reported.And permanently discontinued use of product.Review of complaint description concludes there is no device malfunction.Additional information received from product quality complaint group: manufacturing site assessment: 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 used expired product.Consumer did not report an adverse event occurring.Review of records does not provide evidence to support defective product.Care should be the product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.The previous investigation were not confirmed to have a manufacturing root cause related to the subclass.Per sop-(b)(4), complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify if a potential trend exist for the lot and subclass.No trend was identified.Refer to attachment adverse event serious unknown h43487.On the basis of this evaluation, a trend does not exist for this lot.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.Return sample evaluation: a return sample has not been received at the site.Amendment: this follow-up report is being submitted to amend previously reported information: medical history updated.Follow up (27nov2019): new information received from the product quality complaint group includes severity rating, malfunction assessment and case upgraded to serious, reportable mdr.Follow-up (02dec2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error", "device use issue" and "expired device use" are non-serious.The events were 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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error", "device use issue" and "expired device use" are non-serious.The events were 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.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Event Description
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Event verbatim [preferred term] they last way longer than 12 hours [device issue] , expiration date 18oct2016/consumer was 67 years old when he used it [expired device used] , he also used it on his neck/works on other places of his body [device use issue] , after he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.This 67-years-old male consumer started to receive thermacare heatwrap (thermacare knee & elbow) lot number h43487, expiration date 18oct2016, udi number (b)(4), from unknown date for neck and back hurt.Medical history and concomitant medications were none.Consumer used thermacare knee and elbow heatwrap.They expired 18oct2016.He also used it on his neck.He stated how great they work and they work for other places on his body.The transfer agent told him not to use after expiration or to use other places besides knee and elbow.Consumer clarified not expired date but its probably dated for when it was purchased.He had two more in the box and they last way longer than 12 hours.It lasted for two days.After he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day.He used it twice after using it on his neck he put it in a plastic bag and used it the next day.Consumer was 67 years old when he used it.It had been sitting on the cupboard for a long time.He used at least a year after he bought it or it could have been two.He had stopped using it.He used it for two different days.It had 12 hours of heat.He placed it in a sealed bag.It helped a lot with his neck and lower back.It helped on two different days.He used an ace bandage to keep in place.It helped really good.He bought it because his neck and back hurt.It worked great.Device was available for evaluation.He could send it back.Ultra thin, discrete, and odorless, and comfortable were on there.There were a lot of papers.There were three different products.It had directions on the box.It said ask the doctor before use.Consumer reported he never asked the doctor.He had a little trouble opening up the booklet inside.It said fifty five or older has increased risk of burning.The action taken in response to the events of the product was permanently discontinued.The outcome of the events was unknown.Consumer thought there was not a reasonable possibility that an ae is related to the device.According to the product quality complaint group: severity of harm: s3 for complaint sub-class: adverse event/serious/unknown.A summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced the product being too hot to use no burn injury was reported.And permanently discontinued use of product.Review of complaint description concludes there is no device malfunction.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: medical history updated.Follow up (27nov2019): new information received from the product quality complaint group includes severity rating, malfunction assessment and case upgraded to serious, reportable mdr.Company clinical evaluation comment based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error", "device use issue" and "expired device use" are non-serious.The events were assessed as associated with the use of the device., comment: based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error", "device use issue" and "expired device use" are non-serious.The events were assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] they last way longer than 12 hours/it lasted for two days [device issue] , expiration date 18oct2016/consumer was 67 years old when he used it [expired device used] , he also used it on his neck/works on other places of his body [device use issue] , after he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day [device use error].Case narrative:this is a spontaneous report from a contactable consumer.This 67-year-old male consumer started to receive thermacare heatwrap (thermacare knee & elbow) lot number h43487, expiration date aug2016 (reported as 18oct2016 by consumer), udi number (b)(4), from unknown date for his neck and back hurt.Also provided for one inside the box has "lot number h47687.It is different.Expiration: aug2016 01:14.Sep2021" medical history and concomitant medications were none.He bought it for his daughter, but did not use the product.The consumer used thermacare heatwrap, and they expired on 18oct2016.He also used it on his neck.He stated how great they work and they work for other places on his body.The consumer clarified "not expired date but its probably dated for when it was purchased." they last way longer than 12 hours.It lasted for two days.After he used it for one day, he placed it in a plastic bag and it had life left in it and used for another day.He used it twice after using it on his neck he put it in a plastic bag and used it the next day.It had been sitting on the cupboard for a long time.He used at least a year after he bought it or it could have been two.He had stopped using it.He used it and helped on two different days.It had 12 hours of heat.He placed it in a sealed bag.It helped a lot with his neck and lower back.He used an ace bandage to keep in place.It helped really good.It worked great."ultra thin, discrete, and odorless, and comfortable were on there.There were a lot of papers.There were three different products." it had directions on the box.It said ask the doctor before use.Consumer reported he never asked the doctor.He had a little trouble opening up the booklet inside.It said fifty five or older has increased risk of burning.Packaging was sealed and intact.Device was available for evaluation, and he could send it back.Product count size dispensed: 3 pack; still has 2 of them.The action taken with the product was permanently discontinued.The outcome of the events was unknown.Consumer thought there was not a reasonable possibility that an ae is related to the device.According to the product quality complaint group: severity of harm: s3 for complaint sub-class: adverse event/serious/unknown.An investigation is being performed as providing the batch record information is the manufacturing site's requirement.Additional information received from product quality complaint group: manufacturing site assessment: 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 used expired product.Consumer did not report an adverse event occurring.Review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the manufacturing site requiring an evaluation for this lot.The previous investigation were not confirmed to have a manufacturing root cause related to the subclass.Per complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify if a potential trend exist for the lot and subclass.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assessment & 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.Return sample evaluation: a return sample has not been received at the site.Also provided investigation on class/subclass: non-defect / personal preference | non-defect/ personal preference not classified.Cass/subclass: external cause investigation / adverse event/negligible-minor.Class/subclass: external cause investigation/adverse event/serious/unknown.Reasonably suggests no device malfunction with severity of harm ranking n/a.Capa previously identified and but no capas in place.No full investigation required.Qa review & rationale, summary of investigation, conclusion, and document review summary: refer to evaluation of complaints related to non-defect.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.No reserve sample evaluation and test required.No lot-specific trend and expedite trend were identified.Site sample status: not received.Sterile product: no.Evaluation of complaints related to non-defect subclass: introduction: thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (city name) site is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaint investigations where there is no quality defect.A non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and close with no further action taken.Amendment: this follow-up report is being submitted to amend previously reported information: medical history updated.Follow up (27nov2019): new information received from the product quality complaint group includes severity rating, malfunction assessment and case upgraded to serious, reportable mdr.Follow-up (02dec2019): new information received from product quality complaint group includes investigation results.Follow-up (16dec2019): new information received from the product quality complaint group included: additional lot number and expiration date, updated expiration for lot number h43487 (from 18oct2016 to 31aug2016), additional complaint class and subclass and it's investigations including summary of investigation conclusion and other investigation findings, evaluation of complaints related to non-defect, sample status.Amendment: this follow-up report is being submitted to amend previously reported information: adverse event was unticked for medwatch report type.Company clinical evaluation comment based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error", "device use issue" and "expired device use" are non-serious.The events were 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.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on available information, the patient reported "they last way longer than 12 hours/it lasted for two days" (device issue) which represents a potential device malfunction is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.Other events of "device use error", "device use issue" and "expired device use" are non-serious.The events were 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.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Severity of harm: s3 for complaint sub-class: adverse event/serious/unknown.An investigation is being performed as providing the batch record information is the manufacturing site's requirement.Additional information received from product quality complaint group: manufacturing site assessment: 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 used expired product.Consumer did not report an adverse event occurring.Review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the manufacturing site requiring an evaluation for this lot.The previous investigation were not confirmed to have a manufacturing root cause related to the subclass.Per complaint trending guideline, effective 19nov2019, a visual evaluation was performed to identify if a potential trend exist for the lot and subclass.No trend was identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assessment & 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.
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Search Alerts/Recalls
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