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| Lot Number AD7676 |
| Device Problems
Loss of or Failure to Bond (1068); Insufficient Heating (1287); Unsealed Device Packaging (1444); Use of Device Problem (1670)
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| Patient Problems
Erythema (1840); Pain (1994); Tissue Damage (2104)
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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) 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.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.
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Event Description
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Event verbatim [preferred term] sometimes she put it on her skin/she had been known to cut and divide the neck wraps to go on her knees [device use error] , leaves skin red and raw [erythema] , leaves skin red and raw [skin erosion] , skin is sore [pain of skin] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number ad7676, expiration date oct2021, from 2005 at three patches at a time for an unspecified indication.Medical history included ongoing rare type of cancer, the cancer made it hard for her, it was in her brain as well and makes hard to function, lost height because of disc degeneration, has other medical issues going on and it affects her capability in response and understanding things.The patient's concomitant medications were not reported.The patient stated with this package of the thermacare heatwraps neck, shoulder, wrist, came in all the rest were fine.Not sure, she did not remember if was 3 or 4 in the package.Stated this had happened a couple of times, the same thing happened last year, but she was too ill to follow up.Stated she was calling to make us aware because she was sure we do not want the product going out like this.Stated it did not get sealed well.The sealing quit at the silver line under thermacare.There was one other time when it happened and she was able to call and let us know.She added when take it out of the box the packets are usually pliable, but with this one the little iron ions were stone like inside the heatwrap, the heat cells.It had lost it's power due to being unsealed.They are stone like.She stated after the lot number sees: n11/14.No longer had the box to provide upc code.Sample status is not available.She took them out of the box.Mentioned she had taken these out of the box to place in bag to go to hospital with and did not want to keep box with her.She wanted packing to be as low as she could get it.She used the thermacare product throughout her body.She went on to explain 25 years ago she was told she had the skeletal system of someone in their 80s.The weather changes, depending on gastric issues, and other things makes her have to use thermacare heatwrap, or the thermacare ointment/lotion.She added in call that the sometime the thermacare neck, shoulder, and wrist comes loose.It came loose easily majority of the time it is applied.Sometime had to reinforce it with some type of medical tape to get it to stay.Stated sometimes she put it on her skin that is tender and it left skin red and raw, could be from the different tape in place.Whenever she made a trip to medical care she may have 3-4 heatwraps on.There was a time where she had six on to hit the spots that were most painful.If skin was sore or red she applies antiseptic powder.She applied it to keep it dry and use different tape.The patient had been in the hospital recently and had to have two emergency transfusions due to a rare blood cancer that she had.This was a wonderful product that she had been using.She was told about the product in 2005.She had used them religiously.She always restocked when she got low.She had severe degenerative disc disease along with other situations that she was dealing with.The thermacare patches went with her in the ambulance when she had to have the transfusions.The doctors and nurses did not know about them.She was working with a blood deficiency of 45-50%.The package she was holding, the wrap did not make it into the package and it allows air into the package and it is already air activated.She did not have upc, udi, lot number and expiration date for the previous affected packages.She said that there was no cure for this cancer.The lifespan was 4 years after diagnosis.She was 2.5 years after diagnosis.She started using thermacare in 2005.She sometimes will use three patches at a time.She had been known to cut and divide the neck wraps to go on her knees and use additional tape.She said that the adhesive sticking to her skin.She always had to use silk tape to keep them on after just a few hours.She did not have the upc, udi, lot number or expiration date for the product that she cut or used tape on to hold it on.She said that with the different products, they didn't fit on her the way she needed them to.She couldn't work with them and used tape on them.She didn't put the tape on the heating cells and used the silk tape to keep them on.She said that mayo won't take her as a patient and she had been denied by other facilities that won't accept her.The action taken in response to the events was unknown.The outcome of the events was unknown.The physician stated the patient did not provide information regarding the adverse event(s) with the use of the product.According to product quality complaints group, 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) 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.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.The severity of pouch leaks is s1 no harm to customer.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour, effective (b)(6) 2019, no further investigation or action required.Complaint sub-class: adverse event/serious/unknown.Severity of harm: s3.Product quality complaints provided the following additional investigation results for batch # ad7676 on 04oct2019: batch # is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Sample is not available to confirm a defect.The consumer reported the wrap "leaves skin red and raw." the cause of the wrap leaving the "skin red and raw" is inconclusive since it is not clear what cause a device malfunction.The review of records does not provide evidence to support defective product.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Review of the batch device history record for this batch concludes all release requirements were met.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c) per neck, shoulder & wrist (nsw) 8hr.The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.The material records for sca laminate, material number #, were reviewed.There were two batches of sca used in the manufacturing of this batch, # and #.There were no supplier incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-# retain sample inspection form documented the retain evaluation performed for a previous complaint.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.Follow-up (21may2019): new information received from a product quality complaints group included: investigation results.Follow-up (23may2019): new information received from a contactable other-hcp included: new reporter.Follow-up (31may2019): new information received from the product quality complaint group includes product investigation summary results.Follow-up (22jul2019): new information received from a contactable physician included: new reporter and deny of acknowledge of the events.Follow up (28aug2019 and 04sep2019): new information from product quality complaints group included: severity level.New information received from the consumer included: suspect product data (dose), new events (she has been in the hospital recently and had to have two emergency transfusions due to a rare blood cancer, blood deficiency of 45-50%, she had been known to cut and divide the neck wraps to go on her knees), treatment received, and case upgraded to serious (hospitalized).Follow-up (04oct2019): new information received from a product quality complaint group includes: additional investigation results for lot# ad7979.The events device use error, erythema, skin erosion, and pain of skin were re-assessed as serious, and the case is upgraded to reportable medical device report.Company clinical evaluation comment: based on the information provided, the events of "sometimes she put it on her skin/she had been known to cut and divide the neck wraps to go on her knees; and leaves skin red and raw, skin is sore" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events 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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "sometimes she put it on her skin/she had been known to cut and divide the neck wraps to go on her knees; and leaves skin red and raw, skin is sore" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events 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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Conclusion for complaint subclass "squeeze tube/pouch/stick pack damage/defect" and subclass "adverse event safety request for investigation": 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, surly 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) 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.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.The severity of pouch leaks is s1 no harm to customer.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour, effective 23apr2019, no further investigation or action required.Complaint sub-class: adverse event/serious/unknown.Severity of harm: s3.Product quality complaints provided the following additional investigation results for batch # ad7676 on 04oct2019: batch # is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Sample is not available to confirm a defect.The consumer reported the wrap "leaves skin red and raw." the cause of the wrap leaving the "skin red and raw" is inconclusive since it is not clear what cause a device malfunction.The review of records does not provide evidence to support defective product.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Review of the batch device history record for this batch concludes all release requirements were met.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c) per neck, shoulder & wrist (nsw) 8hr.The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.The material records for sca laminate, material number #, were reviewed.There were two batches of sca used in the manufacturing of this batch, # and #.There were no supplier incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-# retain sample inspection form documented the retain evaluation performed for a previous complaint.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.
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Event Description
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Event verbatim [preferred term].Leaves skin red and raw [erythema], leaves skin red and raw [skin erosion], skin is sore [pain of skin], she had been known to cut and divide the neck wraps to go on her knees [device use issue].Narrative: this is a spontaneous report from a contactable consumer, physician and other hcp.A 69-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number ad7676, expiration date oct2021, from 2005 at three patches at a time for an unspecified indication.Medical history included ongoing rare type of cancer/blood cancer, the cancer made it hard for her, it was in her brain as well and made hard to function, lost height because of disc degeneration, has other medical issues going on and it affected her capability in response and understanding things.The patient's concomitant medications were not reported.The patient stated with this package of the thermacare heatwraps neck, shoulder, wrist, came in all the rest were fine.Not sure, she did not remember if was 3 or 4 in the package.Stated this had happened a couple of times, the same thing happened last year, but she was too ill to follow up.Stated she was calling to make us aware because she was sure we do not want the product going out like this.Stated it did not get sealed well.The sealing quit at the silver line under thermacare.There was one other time when it happened and she was able to call and let us know.She added when take it out of the box the packets are usually pliable, but with this one the little iron ions were stone like inside the heatwrap, the heat cells.It had lost it's power due to being unsealed.They are stone like.She stated after the lot number sees: n11/14.No longer had the box to provide upc code.Sample status is not available.She took them out of the box.Mentioned she had taken these out of the box to place in bag to go to hospital with and did not want to keep box with her.She wanted packing to be as low as she could get it.She used the thermacare product throughout her body.She went on to explain 25 years ago she was told she had the skeletal system of someone in their 80s.The weather changes, depending on gastric issues, and other things makes her have to use thermacare heatwrap, or the thermacare ointment/lotion.She added in call that the sometime the thermacare neck, shoulder, and wrist comes loose.It came loose easily majority of the time it is applied.Sometime had to reinforce it with some type of medical tape to get it to stay.Stated sometimes she put it on her skin that is tender and it left skin red and raw, could be from the different tape in place.Whenever she made a trip to medical care she may have 3-4 heatwraps on.There was a time where she had six on to hit the spots that were most painful.If skin was sore or red she applies antiseptic powder.She applied it to keep it dry and use different tape.The patient had been in the hospital recently and had to have two emergency transfusions due to a rare blood cancer that she had.This was a wonderful product that she had been using.She was told about the product in 2005.She had used them religiously.She always restocked when she got low.She had severe degenerative disc disease along with other situations that she was dealing with.The thermacare patches went with her in the ambulance when she had to have the transfusions.The doctors and nurses did not know about them.She was working with a blood deficiency of 45-50%.The package she was holding, the wrap did not make it into the package and it allows air into the package and it is already air activated.She did not have upc, udi, lot number and expiration date for the previous affected packages.She said that there was no cure for this cancer.The lifespan was 4 years after diagnosis.She was 2.5 years after diagnosis.She started using thermacare in 2005.She sometimes will use three patches at a time.She had been known to cut and divide the neck wraps to go on her knees and use additional tape.She said that the adhesive sticking to her skin.She always had to use silk tape to keep them on after just a few hours.She did not have the upc, udi, lot number or expiration date for the product that she cut or used tape on to hold it on.She said that with the different products, they didn't fit on her the way she needed them to.She couldn't work with them and used tape on them.She didn't put the tape on the heating cells and used the silk tape to keep them on.She said that mayo won't take her as a patient and she had been denied by other facilities that won't accept her.The action taken in response to the events was unknown.The outcome of the events was unknown.The physician stated the patient did not provide information regarding the adverse event(s) with the use of the product.According to product quality complaints group: conclusion for complaint subclass "squeeze tube/pouch/stick pack damage/defect" and subclass " adverse event safety request for investigation": 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) 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.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.The severity of pouch leaks is s1 no harm to customer.Investigation summary: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adhesion/fastening defect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour, effective 23apr2019, no further investigation or action required.Complaint sub-class: adverse event/serious/unknown.Severity of harm: s3.Product quality complaints provided the following additional investigation results for batch # ad7676 on 04oct2019: batch # is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Sample is not available to confirm a defect.The consumer reported the wrap "leaves skin red and raw." the cause of the wrap leaving the "skin red and raw" is inconclusive since it is not clear what cause a device malfunction.The review of records does not provide evidence to support defective product.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Review of the batch device history record for this batch concludes all release requirements were met.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c) per neck, shoulder & wrist (nsw) 8hr.The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.The material records for sca laminate, material number #, were reviewed.There were two batches of sca used in the manufacturing of this batch, # and #.There were no supplier incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-# retain sample inspection form documented the retain evaluation performed for a previous complaint.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.Follow-up (21may2019): new information received from a product quality complaints group included: investigation results.Follow-up (23may2019): new information received from a contactable other-hcp included: new reporter.Follow-up (31may2019): new information received from the product quality complaint group includes product investigation summary results.Follow-up (22jul2019): new information received from a contactable physician included: new reporter and deny of acknowledge of the events.Follow up (28aug2019 and 04sep2019): new information from product quality complaints group included: severity level.New information received from the consumer included: suspect product data (dose), new events (she has been in the hospital recently and had to have two emergency transfusions due to a rare blood cancer, blood deficiency of 45-50%, she had been known to cut and divide the neck wraps to go on her knees), treatment received, and case upgraded to serious (hospitalized).Follow-up (04oct2019): new information received from a product quality complaint group includes: additional investigation results for lot# ad7979.The events device use error, erythema, skin erosion, and pain of skin were re-assessed as serious, and the case is upgraded to reportable medical device report.Follow-up (27dec2019): follow-up attempts completed.No further information expected.Follow-up (12aug2019): new information received from the product quality complaint group included additional complaint sub-class: adverse event safety request for investigation.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of "sometimes she put it on her skin/she had been known to cut and divide the neck wraps to go on her knees; and leaves skin red and raw, skin is sore" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events 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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Search Alerts/Recalls
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