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| Lot Number S97473;W91244 |
| Device Problems
Overheating of Device (1437); Excessive Heating (4030)
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| Patient Problem
Skin Inflammation (2443)
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| Event Date 04/01/2019 |
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Event Type
malfunction
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Event Description
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Event verbatim [preferred term] area on his back stayed red [erythema] , when the wrap was applied the patient just said that it was really hot/it was too hot [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for her husband.A (b)(6) male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s97473, expiration date mar2020, upc number (b)(4), from (b)(6) 2019 at applied over a t-shirt approximately 2 hours as lower back was bothering him.Medical history was none.There were no concomitant medications.The reporter had a product affected by the thermacare heatwrap recall with lot: s97473 and expiration date: mar2020.One of the heatwraps in the box was used.The reporter reported that she applied the affected thermacare back pain therapy heatwraps wrap to the patient, over his t-shirt on his back.When the wrap was applied the patient just said that it was really hot in (b)(6) 2019, but maybe that was just what it was supposed to do.This event was the first time the patient had ever used this product.He kept the wrap on for approximately 2 hours before he said he had to take it off because it was too hot in (b)(6) 2019.Product was removed and discarded, and the second wrap from this package had not been opened or applied.The reporter reported that regarding these events that the patient recovered with lasting effect of the area on his back stayed red for like a day or so in (b)(6) 2019.The patient did not go to primary prescriber for this event.The reporter had retained the outer packaging and the sealed unopened wrap remaining in the package, but had discarded the wrap involved in these events.The reporter verified that there had been no testing, treatment, or other medical interventions performed related to these events.Packaging was sealed and intact.The reporter reported seriousness criteria as malfunction.The action taken in response to the events for thermacare heatwrap was permanently withdrawn in (b)(6) 2019.The outcome of the events was resolved in (b)(6) 2019.The reporter reported there was reasonable possibility that the events were related to the device.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the available information, the patient reported that when the wrap was applied the patient just said that it was really hot/it was too hot and area on his back stayed red.The event area on his back stayed red was more likely caused by the wrap that was too hot.There was no burn, or burn blister associated with the use of the device.This malfunction the reporter alleged has a theoretical risk to cause skin burn.The events are medically assessed as associated with the use of the device.The case will be reassessed if relevant additional medical information becomes available., comment: based on the available information, the patient reported that when the wrap was applied the patient just said that it was really hot/it was too hot and area on his back stayed red.The event area on his back stayed red was more likely caused by the wrap that was too hot.There was no burn, or burn blister associated with the use of the device.This malfunction the reporter alleged has a theoretical risk to cause skin burn.The events are medically assessed as associated with the use of the device.The case will be reassessed if relevant additional medical information becomes available.
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Manufacturer Narrative
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Summary of investigation for batch#: w91244: batch w91244 is the only batch within the scope of this investigation.Thermacare batches are produced as individuals lots.Heatwrap recall with lot number provided does match the recall.Caller chose to be reimbursed via check instead of having product replacement sent.Conclusion: the root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch for the sub class of too hot.Evaluation of the returned sample did not provide any additional information as to why the consumer stated the wrap "was too hot".An emerging trend for lbh product for the subclass was noted.(b)(4) was completed to identify a root cause for the trend of the subclass too hot.(b)(4) identified the increase in complaints received in may 2019 for lbh was due to the recall in april 2019 for lbh batches s97473, s00639, s23902, w37940.An evaluation of the complaint history confirms that this is the no trend identified for the batch.Second complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had been received at the site.Date samples were received (gmt): 16-may-2019.Lbh (l) w91244, exp jul2021.Carton is opened by consumer.Pouch is sealed, no obvious defects.One wrap is inside sealed pouch.Initial complaint assessment for batch code#: s97473: batch s97473 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per spec 23451, effective: 28nov2016.There were no wrap attribute or variable defects recorded for the batch that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.All site investigations associated with this batch were closed prior to releasing the batch.
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Event Description
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Event verbatim [preferred term].Area on his back stayed red [erythema], when the wrap was applied the patient just said that it was really hot/it was too hot [device issue].Narrative: this is a spontaneous report from a contactable consumer reported for her husband.A 66-years-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s97473, expiration date mar2020, upc number 305733-01003; device lot number w91244, expiration date jul2021; from (b)(6) 2019 to (b)(6) 2019 at applied over a t-shirt approximately 2 hours as lower back was bothering him.Medical history was none.There were no concomitant medications.The reporter had a product affected by the thermacare heatwrap recall with lot: s97473 and expiration date: mar2020.One of the heatwraps in the box was used.The reporter reported that she applied the affected thermacare back pain therapy heatwraps wrap to the patient, over his t-shirt on his back.When the wrap was applied the patient just said that it was really hot in (b)(6) 2019, but maybe that was just what it was supposed to do.This event was the first time the patient had ever used this product.He kept the wrap on for approximately 2 hours before he said he had to take it off because it was too hot in (b)(6) 2019.Used product was removed and discarded, and the second wrap from this package had not been opened or applied.The reporter reported that regarding these events that the patient recovered with lasting effect of the area on his back stayed red for like a day or so in (b)(6) 2019.The patient did not go to primary prescriber for this event.The reporter had retained the outer packaging and the sealed unopened wrap remaining in the package, but had discarded the wrap involved in these events.The reporter verified that there had been no testing, treatment, or other medical interventions performed related to these events.Packaging was sealed and intact.The reporter reported seriousness criteria as malfunction.Per investigating site the return sample was received and was lbh batch w91244, exp jul2021.Reporter verified the lot number the defect occurred with was w91244.The action taken in response to the events for thermacare heatwrap was permanently withdrawn in (b)(6) 2019.The outcome of the events was resolved in apr2019.The reporter reported there was reasonable possibility that the events were related to the device.According to product quality complaint group: summary of investigation for batch#: w91244: batch w91244 is the only batch within the scope of this investigation.Thermacare batches are produced as individuals lots.Heatwrap recall with lot number provided does match the recall.Caller chose to be reimbursed via check instead of having product replacement sent.Conclusion: the root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch for the sub class of too hot.Evaluation of the returned sample did not provide any additional information as to why the consumer stated the wrap "was too hot".An emerging trend for lbh product for the subclass was noted.(b)(4) was completed to identify a root cause for the trend of the subclass too hot.(b)(4) identified the increase in complaints received in may 2019 for lbh was due to the recall in april 2019 for lbh batches s97473, s00639, s23902, w37940.An evaluation of the complaint history confirms that this is the no trend identified for the batch.Second complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had been received at the site.Date samples were received (gmt): 16-may-2019.Lbh (l) w91244, exp jul2021.Carton is opened by consumer.Pouch is sealed, no obvious defects.One wrap is inside sealed pouch.Initial complaint assessment for batch code#: s97473: batch s97473 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per spec 23451, effective: 28nov2016.There were no wrap attribute or variable defects recorded for the batch that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.All site investigations associated with this batch were closed prior to releasing the batch.Follow-up (02jul2019): follow-up attempts are completed.No further information is expected.Follow-up (11sep2019): new information from a product quality complaint group includes: investigation results.No follow up attempts needed.No further information is expected., comment:.
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Manufacturer Narrative
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Summary of investigation for batch#: w91244: batch w91244 is the only batch within the scope of this investigation.Thermacare batches are produced as individuals lots.Heatwrap recall with lot number provided does match the recall.Caller chose to be reimbursed via check instead of having product replacement sent.Conclusion: the root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch for the sub class of too hot.Evaluation of the returned sample did not provide any additional information as to why the consumer stated the wrap "was too hot".An emerging trend for lbh product for the subclass was noted.(b)(4) was completed to identify a root cause for the trend of the subclass too hot.(b)(4) identified the increase in complaints received in may 2019 for lbh was due to the recall in april 2019 for lbh batches s97473, s00639, s23902, w37940.An evaluation of the complaint history confirms that this is the no trend identified for the batch.Second complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had been received at the site.Date samples were received (gmt): 16-may-2019.Lbh (l) w91244, exp jul2021.Carton is opened by consumer.Pouch is sealed, no obvious defects.One wrap is inside sealed pouch.The following updated conclusion information was provided by product quality complaints for batch#: w91244: there was no reasonable suggestion of malfunction.Investigation reopened on 27jul2020 to update return sample evaluation to state that the evaluated returned sample was not worn by the consumer.Outcome of investigation not impacted by update of return sample.According to rpt-# section # - market actions (recall), effective date: 30apr2020, in apr2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower, back and hip, include s97473 (us), s00639 (country name/ country name), s23902 (country name / country name), and w37940 (country name / country name).The recall action was taken after the batches were released with an out of specification result for high temperature cell(s) and no product isolation of impacted product was performed.Release of these batches without product isolation is a compliance gap.The manufacturing investigation (pr #, closed 04sep2019) resulted in corrective actions including improving procedures for containing and investigating nonconforming product.Initial complaint assessment for batch code#: s97473: batch s97473 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per spec 23451, effective: 28nov2016.There were no wrap attribute or variable defects recorded for the batch that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.All site investigations associated with this batch were closed prior to releasing the batch.Product quality complaints provided the following conclusion for batch # s97473: the root cause category is non assignable (complaint not confirmed as quality defect).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.Product has expired at the time of this compliant investigation.No trends were identified for the batch.The returned sample has not been received at the site for evaluation.This batch was involved in investigation pr #; opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.According to rpt-# section #- market actions (recall), effective date: 30apr2020, in apr2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower, back and hip, include s97473 (country name withheld), s00639 (country name withheld), s23902 (country name withheld), and w37940 (country name withheld).The recall action was taken after the batches were released with an out of specification result for high temperature cell(s) and no product isolation of impacted product was performed.Release of these batches without product isolation is a compliance gap.The manufacturing investigation resulted in corrective actions including improving procedures for containing and investigating nonconforming product.The citi customizable search returned a total of 70 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of wrap/patch/pad too hot.Based on this citi search, there is a trend emerging in may2019 for the subclass of too hot for lbh products.Exped trend actions taken: the spike of complaints received in may2019 for wrap/patch/pad too hot was due to the recall of apr2019 for lbh batches s97473, s00639, s23902, w37940.According to rpt-38832 section 10.1 - market actions (recall), effective date: 30apr2020, in apr2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower, back and hip, include s97473 (country name withheld), s00639 (country name withheld), s23902 (country name withheld), and w37940 (country name withheld).The recall action was taken after the batches were released with an out of specification result for high temperature cell(s) and no product isolation of impacted product was performed.Release of these batches without product isolation is a compliance gap.The manufacturing investigation resulted in corrective actions including improving procedures for containing and investigating nonconforming product.Investigation pr # (closed 04sep2019) was completed for the trend of too hot for lbh product.There was no device malfunction identified for batches w59249, ad3849, w91244.
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Event Description
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Event verbatim [preferred term].Area on his back stayed red [erythema], when the wrap was applied the patient just said that it was really hot/it was too hot [device issue].Narrative: this is a spontaneous report from a contactable consumer reported for her husband.A 66-years-old male patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s97473, expiration date mar2020, upc number 305733-01003; device lot number w91244, expiration date jul2021; from (b)(6) 2019 to (b)(6) 2019 at applied over a t-shirt approximately 2 hours as lower back was bothering him.Medical history was none.There were no concomitant medications.The reporter had a product affected by the thermacare heatwrap recall with lot: s97473 and expiration date: mar2020.One of the heatwraps in the box was used.The reporter reported that she applied the affected thermacare back pain therapy heatwraps wrap to the patient, over his t-shirt on his back.When the wrap was applied the patient just said that it was really hot in (b)(6) 2019, but maybe that was just what it was supposed to do.This event was the first time the patient had ever used this product.He kept the wrap on for approximately 2 hours before he said he had to take it off because it was too hot in (b)(6) 2019.Used product was removed and discarded, and the second wrap from this package had not been opened or applied.The reporter reported that regarding these events that the patient recovered with lasting effect of the area on his back stayed red for like a day or so in (b)(6) 2019.The patient did not go to primary prescriber for this event.The reporter had retained the outer packaging and the sealed unopened wrap remaining in the package, but had discarded the wrap involved in these events.The reporter verified that there had been no testing, treatment, or other medical interventions performed related to these events.Packaging was sealed and intact.The reporter reported seriousness criteria as malfunction.Per investigating site the return sample was received and was lbh batch w91244, exp jul2021.Reporter verified the lot number the defect occurred with was w91244.The action taken in response to the events for thermacare heatwrap was permanently withdrawn in (b)(6) 2019.The outcome of the events was resolved in (b)(6) 2019.The reporter reported there was reasonable possibility that the events were related to the device.According to product quality complaint group: summary of investigation for batch#: w91244: batch w91244 is the only batch within the scope of this investigation.Thermacare batches are produced as individuals lots.Heatwrap recall with lot number provided does match the recall.Caller chose to be reimbursed via check instead of having product replacement sent.Conclusion: the root cause category is non-assignable (complaint not confirmed).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.No trends were identified for the batch for the sub class of too hot.Evaluation of the returned sample did not provide any additional information as to why the consumer stated the wrap "was too hot".An emerging trend for lbh product for the subclass was noted.(b)(4) was completed to identify a root cause for the trend of the subclass too hot.(b)(4) identified the increase in complaints received in may 2019 for lbh was due to the recall in april 2019 for lbh batches s97473, s00639, s23902, w37940.An evaluation of the complaint history confirms that this is the no trend identified for the batch.Second complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.The sample had been received at the site.Date samples were received (gmt): 16-may-2019.Lbh (l) w91244, exp jul2021.Carton is opened by consumer.Pouch is sealed, no obvious defects.One wrap is inside sealed pouch.The following updated conclusion information was provided by product quality complaints for batch#: w91244: there was no reasonable suggestion of malfunction.Investigation reopened on 27jul2020 to update return sample evaluation to state that the evaluated returned sample was not worn by the consumer.Outcome of investigation not impacted by update of return sample.According to rpt-# section # - market actions (recall), effective date: 30apr2020, in apr2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower, back and hip, include s97473 (us), s00639 (country name/ country name), s23902 (country name / country name), and w37940 (country name / country name).The recall action was taken after the batches were released with an out of specification result for high temperature cell(s) and no product isolation of impacted product was performed.Release of these batches without product isolation is a compliance gap.The manufacturing investigation (pr #, closed 04sep2019) resulted in corrective actions including improving procedures for containing and investigating nonconforming product.Initial complaint assessment for batch code#: s97473: batch s97473 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class too hot received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per spec 23451, effective: 28nov2016.There were no wrap attribute or variable defects recorded for the batch that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.All site investigations associated with this batch were closed prior to releasing the batch.Product quality complaints provided the following conclusion for batch # s97473: there was no reasonable suggestion of device malfunction.A return sample has not been received as of 05aug2020.The root cause category is non assignable (complaint not confirmed as quality defect).Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.Product has expired at the time of this compliant investigation.No trends were identified for the batch.The returned sample has not been received at the site for evaluation.This batch was involved in investigation pr #; opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.According to rpt-# section #- market actions (recall), effective date: 30apr2020, in apr2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower, back and hip, include s97473 (country name withheld), s00639 (country name withheld), s23902 (country name withheld), and w37940 (country name withheld).The recall action was taken after the batches were released with an out of specification result for high temperature cell(s) and no product isolation of impacted product was performed.Release of these batches without product isolation is a compliance gap.The manufacturing investigation resulted in corrective actions including improving procedures for containing and investigating nonconforming product.The citi customizable search returned a total of 70 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of wrap/patch/pad too hot.Based on this citi search, there is a trend emerging in may2019 for the subclass of too hot for lbh products.Exped trend actions taken: the spike of complaints received in may2019 for wrap/patch/pad too hot was due to the recall of apr2019 for lbh batches s97473, s00639, s23902, w37940.According to rpt-38832 section 10.1 - market actions (recall), effective date: 30apr2020, in apr2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower, back and hip, include s97473 (country name withheld), s00639 (country name withheld), s23902 (country name withheld), and w37940 (country name withheld).The recall action was taken after the batches were released with an out of specification result for high temperature cell(s) and no product isolation of impacted product was performed.Release of these batches without product isolation is a compliance gap.The manufacturing investigation resulted in corrective actions including improving procedures for containing and investigating nonconforming product.Investigation pr # (closed 04sep2019) was completed for the trend of too hot for lbh product.There was no device malfunction identified for batches w59249, ad3849, w91244.Follow-up (02jul2019): follow-up attempts are completed.No further information is expected.Follow-up (11sep2019): new information from a product quality complaint group includes: investigation results.Follow-up (28jul2020 and 06aug2020): new information received from a product complaint group includes: updated investigation conclusion for lot # w91244 and conclusion for batch s97473.Follow up attempts are completed.No further information is expected., comment:.
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Search Alerts/Recalls
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