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| Lot Number AD1002 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Rash (2033); Injury (2348)
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| Event Date 11/01/2019 |
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Event Type
Injury
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Event Description
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Not only did it not work but later she noticed she developed a rash [rash], not only did it not work but later she noticed she developed a rash [device ineffective].Case narrative: the initial case was missing the following minimum criteria: no adverse effect, product complaint only.Upon receipt of follow-up information on (02-jan-2020), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.This (b)(6) female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number ad1002s11/06, expiration date oct-2021, for pain, arthritis and shoulder damage.Medical history included double kidney failure.Concomitant medication was not reported.Consumer had arthritis and had used these for years.She had been using these products for a very long time and not had any problems with them.She had met a man who came back from germany who was in the military and he gave her something to help her and she fell in love with it.He told her it was issued by the military and she may not be able to find it.A while later she ended up finding these heat wraps and as soon as she saw them she bought them and had been using the thermacare products since.Over time her pain had become worse so she had been using these regularly.She could not take meds for the pain as she had double kidney failure.Though expensive they were a blessing helping her function by easing the pain.Consumer said she loved this stuff.It's the only thing that was helping her.She just applied one to her neck but it just would not stick.Her husband had to add medical tape onto it so it would stay.He used the tape to over it to keep it on.She used the neck therapy because she had shoulder damage in both shoulders.She stated that back in (b)(6) 2019 she called about the problem she had with the thermacare heat wrap for neck and shoulder pain.Not only did it not work but later she noticed she developed a rash and was not aware of the rash until she went to take a bath.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Reportability determination from (b)(4): the patient used thermacare heatwrap and reported "not only did it not work but later she noticed she developed a rash" is reportable due to the serious injury.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and event cannot be ruled out.Comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and event cannot be ruled out.
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Event Description
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Event verbatim [preferred term] not only did it not work but later she noticed she developed a rash [rash] , not only did it not work but later she noticed she developed a rash [device ineffective].Case narrative:the initial case was missing the following minimum criteria: no adverse effect, product complaint only.Upon receipt of follow-up information on (02jan2020), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.This 73-year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number ad1002s11/06, expiration date oct2021, for pain, arthritis and shoulder damage.Medical history included double kidney failure.Concomitant medication was not reported.Consumer had arthritis and had used these for years.She had been using these products for a very long time and not had any problems with them.She had met a man who came back from germany who was in the military and he gave her something to help her and she fell in love with it.He told her it was issued by the military and she may not be able to find it.A while later she ended up finding these heat wraps and as soon as she saw them she bought them and had been using the thermacare products since.Over time her pain had become worse so she had been using these regularly.She could not take meds for the pain as she had double kidney failure.Though expensive they were a blessing helping her function by easing the pain.Consumer said she loved this stuff.It's the only thing that was helping her.She just applied one to her neck but it just would not stick.Her husband had to add medical tape onto it so it would stay.He used the tape to over it to keep it on.She used the neck therapy because she had shoulder damage in both shoulders.She stated that back in (b)(6) 2019 she called about the problem she had with the thermacare heat wrap for neck and shoulder pain.Not only did it not work but later she noticed she developed a rash and was not aware of the rash until she went to take a bath.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.She still had the wrap and would be willing to send it in.Reportability determination from pfizer device complaint handling unit (dchu): the patient used thermacare heatwrap and reported "not only did it not work but later she noticed she developed a rash" is reportable due to the serious injury.Additional information has been requested and will be provided as it becomes available.Follow-up (13jan2020): new information received from a contactable consumer included: available of the sample.This follow-up report is being submitted to amend previously reported information: "near incident" was ticked.Company clinical evaluation comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and event cannot be ruled out., comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and event cannot be ruled out.
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Event Description
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Event verbatim [preferred term].Not only did it not work but later she noticed she developed a rash [rash] , not only did it not work but later she noticed she developed a rash [device ineffective].Case narrative:the initial case was missing the following minimum criteria: no adverse effect, product complaint only.Upon receipt of follow-up information on (02jan2020), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.This 73-year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number ad1002s11/06, expiration date oct2021, for pain, arthritis and shoulder damage.Medical history included double kidney failure.Concomitant medication was not reported.Consumer had arthritis and had used these for years.She had been using these products for a very long time and not had any problems with them.She had met a man who came back from germany who was in the military and he gave her something to help her and she fell in love with it.He told her it was issued by the military and she may not be able to find it.A while later she ended up finding these heat wraps and as soon as she saw them she bought them and had been using the thermacare products since.Over time her pain had become worse so she had been using these regularly.She could not take meds for the pain as she had double kidney failure.Though expensive they were a blessing helping her function by easing the pain.Consumer said she loved this stuff.It's the only thing that was helping her.She just applied one to her neck but it just would not stick.Her husband had to add medical tape onto it so it would stay.He used the tape to over it to keep it on.She used the neck therapy because she had shoulder damage in both shoulders.She stated that back in (b)(6) 2019 she called about the problem she had with the thermacare heat wrap for neck and shoulder pain.Not only did it not work but later she noticed she developed a rash and was not aware of the rash until she went to take a bath.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.A sample of the wrap was not available to return for evaluation (consumer got rid of it).Reportability determination from pfizer device complaint handling unit (dchu): the patient used thermacare heatwrap and reported "not only did it not work but later she noticed she developed a rash" is reportable due to the serious injury.Additional information has been requested and will be provided as it becomes available.Follow-up (13jan2020): new information received from a contactable consumer included: available of the sample.This follow-up report is being submitted to amend previously reported information: reporting criteria updated to "near incident." follow-up (15jan2020): new information from a contactable consumer includes: sample availability (not available).No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and event cannot be ruled out., comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and event cannot be ruled out.
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Event Description
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Event verbatim [preferred term]: not only did it not work but later she noticed she developed a rash [rash], not only did it not work but later she noticed she developed a rash [device ineffective].Case narrative:the initial case was missing the following minimum criteria: no adverse effect, product complaint only.Upon receipt of follow-up information on (02jan2020), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.This 73-year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number ad1002, expiration date oct2021, for pain, arthritis and shoulder damage.Medical history included double kidney failure.Concomitant medication was not reported.Consumer had arthritis and had used these for years.She had been using these products for a very long time and not had any problems with them.She had met a man who came back from germany who was in the military and he gave her something to help her and she fell in love with it.He told her it was issued by the military and she may not be able to find it.A while later she ended up finding these heat wraps and as soon as she saw them she bought them and had been using the thermacare products since.Over time her pain had become worse so she had been using these regularly.She could not take meds for the pain as she had double kidney failure.Though expensive they were a blessing helping her function by easing the pain.Consumer said she loved this stuff.It's the only thing that was helping her.She just applied one to her neck but it just would not stick.Her husband had to add medical tape onto it so it would stay.He used the tape to over it to keep it on.She used the neck therapy because she had shoulder damage in both shoulders.She stated that back in (b)(6) 2019 she called about the problem she had with the thermacare heat wrap for neck and shoulder pain.Not only did it not work but later she noticed she developed a rash and was not aware of the rash until she went to take a bath.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.A sample of the wrap was not available to return for evaluation (consumer got rid of it).Product quality complaints provided the following information regarding evaluation of complaints related to open pouches (never worked, squeeze tube, did not last long enough and too cool): the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1- no harm to customer.There was reasonable suggestion of device malfunction.In 2013 a complaint trend was opened for the pouch seal defect (major attribute tested to an aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.The consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation.Complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of realease, the severity of pouch leaks is s1 - no harm to customer, complaints related to pouch seal have been thoroughly investigated and root cause is well understood, leak rate for the current technology is about 2000 ppm, capa is in-place to replace the ultrasonic sealers with heat seal technology.Follow-up (13jan2020): new information received from a contactable consumer included: available of the sample.This follow-up report is being submitted to amend previously reported information: reporting criteria updated to "near incident." follow-up (15jan2020): new information from a contactable consumer includes: sample availability (not available).No follow-up attempts are possible.No further information is expected.Follow-up (05feb2020): new information received from a product quality complaints includes updated lot # and investigation results for complaints related to open pouches.Company clinical evaluation comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and 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.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and 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.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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The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1- no harm to customer.There was reasonable suggestion of device malfunction.In 2013 a complaint trend was opened for the pouch seal defect (major attribute tested to an aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.The consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch fl.
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Manufacturer Narrative
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The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1- no harm to customer.There was reasonable suggestion of device malfunction.In 2013 a complaint trend was opened for the pouch seal defect (major attribute tested to an aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.The consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch fl.
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Event Description
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Event verbatim [preferred term] not only did it not work but later she noticed she developed a rash [rash] , not only did it not work but later she noticed she developed a rash [device ineffective].Case narrative:the initial case was missing the following minimum criteria: no adverse effect, product complaint only.Upon receipt of follow-up information on (02jan2020), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer (patient).A 73-year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number ad1002, expiration date oct2021, for pain, arthritis and shoulder damage.Medical history included double kidney failure.Concomitant medication was not reported.Consumer had arthritis and had used these for years.She had been using these products for a very long time and not had any problems with them.She had met a man who came back from germany who was in the military and he gave her something to help her and she fell in love with it.He told her it was issued by the military and she may not be able to find it.A while later she ended up finding these heat wraps and as soon as she saw them she bought them and had been using the thermacare products since.Over time her pain had become worse so she had been using these regularly.She could not take meds for the pain as she had double kidney failure.Though expensive they were a blessing helping her function by easing the pain.Consumer said she loved this stuff.It's the only thing that was helping her.She just applied one to her neck but it just would not stick.Her husband had to add medical tape onto it so it would stay.He used the tape to over it to keep it on.She used the neck therapy because she had shoulder damage in both shoulders.She stated that back in (b)(6) 2019 she called about the problem she had with the thermacare heat wrap for neck and shoulder pain.Not only did it not work but later she noticed she developed a rash and was not aware of the rash until she went to take a bath.She specified her problem with thermacare heatwrap started in (b)(6) 2019.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.A sample of the wrap was not available to return for evaluation (consumer got rid of it).Product quality complaints provided the following information regarding evaluation of complaints related to open pouches (never worked, squeeze tube, did not last long enough and too cool): the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1- no harm to customer.There was reasonable suggestion of device malfunction.In 2013 a complaint trend was opened for the pouch seal defect (major attribute tested to an aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.The consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation.Complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release, the severity of pouch leaks is s1 - no harm to customer, complaints related to pouch seal have been thoroughly investigated and root cause is well understood, leak rate for the current technology is about 2000 ppm, capa is in-place to replace the ultrasonic sealers with heat seal technology.Follow-up (13jan2020): new information received from a contactable consumer included: available of the sample.This follow-up report is being submitted to amend previously reported information: reporting criteria updated to "near incident.".Follow-up (15jan2020): new information from a contactable consumer includes: sample availability (not available).No follow-up attempts are possible.No further information is expected.Follow-up (05feb2020): new information received from a product quality complaints includes updated lot # and investigation results for complaints related to open pouches.Follow-up (24feb2020): new information from the same contactable consumer included: specification that her problem with thermacare heatwrap started in (b)(6) 2019.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and event cannot be ruled out.Company conducted an investigation, and the most probable root cause for this event was classified (open pouch), capa was implemented, and no further action is recommended.
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Event Description
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Event verbatim [preferred term]: not only did it not work but later she noticed she developed a rash [rash], not only did it not work but later she noticed she developed a rash [device ineffective].Case narrative:the initial case was missing the following minimum criteria: no adverse effect, product complaint only.Upon receipt of follow-up information on (02jan2020), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer (patient).A 73-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), lot number ad1002, expiration date oct2021, for pain, arthritis and shoulder damage.Medical history included double kidney failure.Concomitant medication was not reported.Consumer had arthritis and had used these for years.She had been using these products for a very long time and not had any problems with them.She had met a man who came back from germany who was in the military and he gave her something to help her and she fell in love with it.He told her it was issued by the military and she may not be able to find it.A while later she ended up finding these heat wraps and as soon as she saw them she bought them and had been using the thermacare products since.Over time her pain had become worse so she had been using these regularly.She could not take meds for the pain as she had double kidney failure.Though expensive they were a blessing helping her function by easing the pain.Consumer said she loved this stuff.It's the only thing that was helping her.She just applied one to her neck but it just would not stick.Her husband had to add medical tape onto it so it would stay.He used the tape to over it to keep it on.She used the neck therapy because she had shoulder damage in both shoulders.She stated that back in (b)(6) 2019 she called about the problem she had with the thermacare heat wrap for neck and shoulder pain.Not only did it not work but later she noticed she developed a rash and was not aware of the rash until she went to take a bath.She specified her problem with thermacare heatwrap started in (b)(6) 2019.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.A sample of the wrap was not available to return for evaluation (consumer got rid of it).Product quality complaints provided the following information regarding evaluation of complaints related to open pouches (never worked, squeeze tube, did not last long enough and too cool): the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1- no harm to customer.There was reasonable suggestion of device malfunction.In 2013 a complaint trend was opened for the pouch seal defect (major attribute tested to an aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.The consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation.Complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release, the severity of pouch leaks is s1 - no harm to customer, complaints related to pouch seal have been thoroughly investigated and root cause is well understood, leak rate for the current technology is about 2000 ppm, capa is in-place to replace the ultrasonic sealers with heat seal technology.According to the product quality complaint group on (b)(6) 2020: reasonably suggest device malfunction: yes.Severity of harm was provided as s3.Review of complaint description concludes there is device malfunction.Site sample status was not received.Follow-up (13jan2020): new information received from a contactable consumer included: available of the sample.This follow-up report is being submitted to amend previously reported information: reporting criteria updated to "near incident." follow-up (15jan2020): new information received from a contactable consumer includes: sample availability (not available).Follow-up (05feb2020): new information received from a product quality complaints includes updated lot # and investigation results for complaints related to open pouches.Follow-up (24feb2020): new information received from the same contactable consumer included: specification that her problem with thermacare heatwrap started in (b)(6) 2019.Follow-up (20mar2020): new information received from the product quality complaint group included: malfunction and severity ranking assessment from dchu.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of "rash" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device ineffective was assessed as non-serious.A causal relationship between the device and event cannot be ruled out.Company conducted an investigation, and the most probable root cause for this event was classified (open pouch), capa was implemented, and no further action is recommended.
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Manufacturer Narrative
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The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1- no harm to customer.There was reasonable suggestion of device malfunction.In 2013 a complaint trend was opened for the pouch seal defect (major attribute tested to an aql of 1.5).The trend directly correlates with the implementation of ultrasonic heat seal technology (replace heat seal technology).Since 2013 complaints for this defect have continued to increase at the site.Complaint investigations for pouch sealing are well characterized due to the number of investigations completed over the years.Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Heat seal technology offers a more "forgiving" process to accommodate some of these variations and still achieve a hermetic seal, critical to the functionality and longevity of the thermacare product.The consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch fl.
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Search Alerts/Recalls
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