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| Lot Number AF0351 |
| Device Problems
Insufficient Heating (1287); Material Puncture/Hole (1504)
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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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Manufacturer Narrative
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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.Capa: the (site name) 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, capa see (b)(4).Complaint handling for open pouches: 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 qts.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.
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Event Description
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Around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up [device issue] , did not use the thermacare menstrual for menstrual pain and that she used them for back, shoulder and neck area/using when having pain in back and in shoulder and neck [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer (patient).An about (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual) device lot number laf351, af0351, expiration date sep2021, sap/unique identifier: (b)(4), from an unspecified date at unknown frequency using when having pain in back and in shoulder and neck.There were no medical history and no concomitant medications.The patient previously took thermacare heatwraps, it was when she first started using them at about age (b)(6) and experienced it hurt to have them stuck to her body.The patient stated she used them for a while and then tried the thermacare menstrual pain therapy heatwraps and noticed those were perfect and states those did not hurt her.The patient stated she had used product for years and depended on it and loved it and the one she used was the one called menstrual pain therapy, stated she used it because she did not have to stick it to her body.The patient stated she was now age (b)(6) and did not use the thermacare menstrual pain therapy heatwraps for menstrual pain and that she used them for back, shoulder and neck area.She was unsure of when she began using the thermacare menstrual pain therapy heatwraps but stated it was also around the same time she began using thermacare products about age (b)(6).She stated any of the old thermacare menstrual pain therapy she had used in the past had now been discarded and she did not have the lot numbers, expiry dates, or upc numbers to provide.She got two boxes of the thermacare menstrual pain therapy heatwraps and the individual packages around the wraps some had holes in the packaging.The patient stated there were several that were open, stated that there were four wraps that had open packaging at least and were not filled up and there were gaping holes in the individual packaging.The patient stated that the other box of thermacare menstrual pain therapy heatwraps had a problem and she gave up.There were gaping holes in the packaging of individual wraps in one of the boxes and in the other box there were smaller holes in the individual wrap packaging.The patient stated inside the boxes the wraps were opened and they did not work, clarified to mean by not working she meant they did not heat up.The patient stated one of the wraps was unusable and clarified this means it did not heat up, states she opened several wraps and tried to use them and they did not heat up and noticed the third wrap was also opened in the box.The patient stated for the first box, there were three wraps that did not heat up and all three of those wraps had holes in the individual wrap packaging.The patient stated that the second box of thermacare menstrual pain therapy heatwraps has lot number af0351, exp.Date sep2021, upc (b)(4), she only tried one wrap in this box and it did not heat up, states that on another wrap she could see a hole in the wrap packaging and did not open it, stated for the third wrap she was unsure if it had a hole in the wrap packaging.The patient stated she really did depend on this product because it had helped her a lot and she likes to use it.There was no investigation assessment.The patient was hospitalized for around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up.The action taken was unknown.The outcome of event was not resolved.The device was available for evaluation.Additional information received from product quality complaint (pqc) group included investigation results.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.Capa: the (site name) 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, capa see (b)(4).Complaint handling for open pouches: 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 qts.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.This document will be attached to the complaint record in the global database and closed with no further action taken.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.Follow-up (13feb2019): new information received from the product quality complaint group included investigational results.Follow-up (13mar2019 and 21mar2019): new information received from a contactable consumer included: seriousness criteria (hospitalization) and case upgraded to serious, reportable mdr.New information received from product quality complaint group included investigational results.Company clinical evaluation comment: based on the available information, the patient reported that "around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up" requiring hospital admission.No adverse event was associated with the use of the device.The event was assessed associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended.
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Event Description
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Around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up [device issue] , did not use the thermacare menstrual for menstrual pain and that she used them for back, shoulder and neck area/using when having pain in back and in shoulder and neck [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer (patient).An about 55-year-old female patient started to receive thermacare heatwrap (thermacare menstrual) device lot number: af0351, expiration date sep2021, sap/unique identifier: us (b)(4), from an unspecified date at unknown frequency using when having pain in back and in shoulder and neck.There were no medical history and no concomitant medications.The patient previously took thermacare heatwraps, it was when she first started using them at about age 55 and experienced it hurt to have them stuck to her body.The patient stated she used them for a while and then tried the thermacare menstrual pain therapy heatwraps and noticed those were perfect and states those did not hurt her.The patient stated she had used product for years and depended on it and loved it and the one she used was the one called menstrual pain therapy, stated she used it because she did not have to stick it to her body.The patient stated she was now age 75 and did not use the thermacare menstrual pain therapy heatwraps for menstrual pain and that she used them for back, shoulder and neck area.She was unsure of when she began using the thermacare menstrual pain therapy heatwraps but stated it was also around the same time she began using thermacare products about age 55.She stated any of the old thermacare menstrual pain therapy she had used in the past had now been discarded and she did not have the lot numbers, expiry dates, or upc numbers to provide.She got two boxes of the thermacare menstrual pain therapy heatwraps and the individual packages around the wraps some had holes in the packaging.The patient stated there were several that were open, stated that there were four wraps that had open packaging at least and were not filled up and there were gaping holes in the individual packaging.The patient stated that the other box of thermacare menstrual pain therapy heatwraps had a problem and she gave up.There were gaping holes in the packaging of individual wraps in one of the boxes and in the other box there were smaller holes in the individual wrap packaging.The patient stated inside the boxes the wraps were opened and they did not work, clarified to mean by not working she meant they did not heat up.The patient stated one of the wraps was unusable and clarified this means it did not heat up, states she opened several wraps and tried to use them and they did not heat up and noticed the third wrap was also opened in the box.The patient stated for the first box, there were three wraps that did not heat up and all three of those wraps had holes in the individual wrap packaging.The patient stated that the second box of thermacare menstrual pain therapy heatwraps has lot number: af0351, exp.Date sep2021, upc 0573302002, she only tried one wrap in this box and it did not heat up, states that on another wrap she could see a hole in the wrap packaging and did not open it, stated for the third wrap she was unsure if it had a hole in the wrap packaging.The patient stated she really did depend on this product because it had helped her a lot and she liked to use it.There was no investigation assessment.The patient was hospitalized for around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up.The action taken was unknown.The outcome of event "did not use the thermacare menstrual for menstrual pain and that she used them for back, shoulder and neck area/using when having pain in back and in shoulder and neck" was not resolved.The outcome of the event "around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up" was unknown.The device was available for evaluation.Additional information received from product quality complaint (pqc) group included investigation results.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.Capa: the (site name) 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, capa see pr2557231.Complaint handling for open pouches: 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 qts.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.This document will be attached to the complaint record in the global database and closed with no further action taken.An sample evaluation of was performed for sample returned 11feb2019 for lot#: af0351, expiry sep2021: two menstrual cartons, both cartons are open.Total of six menstrual pouches with three [(l) af0351 n 10/17; exp 2021-09 20:16] and three [(l) af0351 s 10/17; exp 2021-09 20:22].All six pouches have an incomplete seal on one end of the pouch.All six wraps are expired.It is confirmed that the pouches were not properly sealed during manufacturing.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.Follow-up (13feb2019): new information received from the product quality complaint group included investigational results.Follow-up (13mar2019 and 21mar2019): new information received from a contactable consumer included: seriousness criteria (hospitalization) and case upgraded to serious, reportable mdr.New information received from product quality complaint group included investigational results.Follow-up (28mar2019 and 29mar2019): new information received from product quality complaint group includes: return sample evaluation.Follow-up (06may2019): new information received from product quality complaint group to confirm that lot#: laf351 is not a valid lot number so investigation evaluation was not performed for it.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported that "around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up" requiring hospital admission.No adverse event was associated with the use of the device.The event was assessed associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended., comment: based on the available information, the patient reported that "around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up" requiring hospital admission.No adverse event was associated with the use of the device.The event was assessed associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended.
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Manufacturer Narrative
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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.Capa: the (site name) 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, capa see pr2557231.Complaint handling for open pouches: 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 qts.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 t.
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Event Description
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Event verbatim [preferred term] around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up [device issue] , did not use the thermacare menstrual for menstrual pain and that she used them for back, shoulder and neck area/using when having pain in back and in shoulder and neck [intentional device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).An about 55-year-old female patient started to receive thermacare heatwrap (thermacare menstrual) device lot number laf351, af0351, expiration date sep2021, sap/unique identifier: us 00573-3020-00, from an unspecified date at unknown frequency using when having pain in back and in shoulder and neck.There were no medical history and no concomitant medications.The patient previously took thermacare heatwraps, it was when she first started using them at about age 55 and experienced it hurt to have them stuck to her body.The patient stated she used them for a while and then tried the thermacare menstrual pain therapy heatwraps and noticed those were perfect and states those did not hurt her.The patient stated she had used product for years and depended on it and loved it and the one she used was the one called menstrual pain therapy, stated she used it because she did not have to stick it to her body.The patient stated she was now age 75 and did not use the thermacare menstrual pain therapy heatwraps for menstrual pain and that she used them for back, shoulder and neck area.She was unsure of when she began using the thermacare menstrual pain therapy heatwraps but stated it was also around the same time she began using thermacare products about age 55.She stated any of the old thermacare menstrual pain therapy she had used in the past had now been discarded and she did not have the lot numbers, expiry dates, or upc numbers to provide.She got two boxes of the thermacare menstrual pain therapy heatwraps and the individual packages around the wraps some had holes in the packaging.The patient stated there were several that were open, stated that there were four wraps that had open packaging at least and were not filled up and there were gaping holes in the individual packaging.The patient stated that the other box of thermacare menstrual pain therapy heatwraps had a problem and she gave up.There were gaping holes in the packaging of individual wraps in one of the boxes and in the other box there were smaller holes in the individual wrap packaging.The patient stated inside the boxes the wraps were opened and they did not work, clarified to mean by not working she meant they did not heat up.The patient stated one of the wraps was unusable and clarified this means it did not heat up, states she opened several wraps and tried to use them and they did not heat up and noticed the third wrap was also opened in the box.The patient stated for the first box, there were three wraps that did not heat up and all three of those wraps had holes in the individual wrap packaging.The patient stated that the second box of thermacare menstrual pain therapy heatwraps has lot number af0351, exp.Date sep2021, upc 0573302002, she only tried one wrap in this box and it did not heat up, states that on another wrap she could see a hole in the wrap packaging and did not open it, stated for the third wrap she was unsure if it had a hole in the wrap packaging.The patient stated she really did depend on this product because it had helped her a lot and she likes to use it.There was no investigation assessment.The patient was hospitalized for around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up.The action taken was unknown.The outcome of event was not resolved.The device was available for evaluation.Additional information received from product quality complaint (pqc) group included investigation results.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.Capa: the (site name) 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, capa see pr2557231.Complaint handling for open pouches: 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 qts.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.This document will be attached to the complaint record in the global database and closed with no further action taken.An sample evaluation of was performed for sample returned 11feb2019 for lot # af0351, expiry sep2021: two menstrual cartons, both cartons are open.Total of six menstrual pouches with three [(l) af0351 n 10/17; exp 2021-09 20:16] and three [(l) af0351 s 10/17; exp 2021-09 20:22].All six pouches have an incomplete seal on one end of the pouch.All six wraps are expired.It is confirmed that the pouches were not properly sealed during manufacturing.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.Follow-up (13feb2019): new information received from the product quality complaint group included investigational results.Follow-up (13mar2019 and 21mar2019): new information received from a contactable consumer included: seriousness criteria (hospitalization) and case upgraded to serious, reportable mdr.New information received from product quality complaint group included investigational results.Follow-up (28mar2019 and 29mar2019): new information received from product quality complaint group includes: return sample evaluation.Company clinical evaluation comment: based on the available information, the patient reported that "around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up" requiring hospital admission.No adverse event was associated with the use of the device.The event was assessed associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended., comment: based on the available information, the patient reported that "around the wraps some had holes in the packaging/thermacare menstrual pain therapy heatwraps did not heat up" requiring hospital admission.No adverse event was associated with the use of the device.The event was assessed associated with the use of the device.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended.
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Manufacturer Narrative
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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.Capa: the (site name) 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, capa see pr2557231.Complaint handling for open pouches: 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 qts.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.
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Search Alerts/Recalls
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