|
PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT
|
Back to Search Results |
|
| Lot Number W24915; 202259;X25942;X70537;A |
| Device Problems
Insufficient Heating (1287); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Erythema (1840); Increased Sensitivity (2065); Skin Discoloration (2074); Burn, Thermal (2530)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Conclusion: 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 adverse event safety report for investigation.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 01mar2016 through 05/31/2019/ manufacturing site: pfizer (name)/complaint class: external cause.Investigation/complaint sub class: adverse event safety report for investigation.The citi search returned a total of 36 complaints for joint therapy 8 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety report for investigation.A citi complaint trend search was conducted for the subclass adverse event safety report for investigation for joint therapy 8 hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety report for investigation for joint therapy 8hr products.There is no further action required.
|
| |
|
Event Description
|
|
Burnt skin/they burn your skin [thermal burn], had some dark spots from the product/ red spots/ the spots have turned very dark/ dark spots on either side of lower spine [macule], skin discoloration/ skin on her back is a different color now/ spots on her skin are really dark [skin discolouration], skin is sensitive [sensitive skin].Case narrative: this is a spontaneous report from a contactable consumer.An elderly female consumer started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) lot number w24915, lot number 202259 and expiry date: mar2021, from unknown date "for a long time" 4-5 years before (from 2014 to 2015) as it really helped with pain in her back/lower back pain.Medical history was not reported.There were no concomitant medications.Consumer had some dark spots from the product, and she asked will her skin discoloration go back to normal.She did wear the wrap over a layer of clothing.She had used thermacare long term, and she was sure her doctor wouldn't know what this was.She couldn't find the product in stores, her pharmacist told her they are recalled, so she ordered more from (website).She had red spots after wearing the wraps, but now the spots have turned very dark.The patient reports the skin on her back is a different color now and spots on her skin are really dark.She didn't wear them daily, just occasionally when her back goes out.She wanted to get rid of the spots and pfizer should know how to get rid of the spots.She thought the recall was more than what you were explaining.Upon follow up on 06mar2019, the consumer further reported that skin discoloration (still there) started 4-5 years (from 2014 or 2015).Left with the sensitivity on lower back on spots.She doesn't feel the spots will ever leave nor with the sense of feeling on spots.Burnt skin.When probed udi number, she said, "to many and never kept boxes or wraps they came but they burn your skin.Skin is sensitive." she also reported, "i wish i never used them- dark spots on either side of lower spine - should be able to sue for marks sensation when touching the marks.Bad item." the consumer was not hospitalized and did not receive any treatment for the event skin discoloration.The action taken in response to the event of the product was permanently withdrawn on an unspecified date.The outcome of the event skin discoloration was not recovered.The outcome of other events was unknown.Additional information received from product quality complaint (pqc) group included conclusion: 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 adverse event safety report for investigation.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 01mar2016 through 05/31/2019/ manufacturing site: pfizer (name)/complaint class: external cause.Investigation/complaint sub class: adverse event safety report for investigation.The citi search returned a total of 36 complaints for joint therapy 8 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety report for investigation.A citi complaint trend search was conducted for the subclass adverse event safety report for investigation for joint therapy 8 hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety report for investigation for joint therapy 8hr products, refer to the attached trend chart for mar2016 - mar2019.There is no further action required.Severity of harm: s3.Additional information received from product quality complaint (pqc) group included conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "skin on her back is a different color".The cause of the different color on skin is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Document review summary: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 (37.6°c to 41.6°c) per (b)(4); effective date: 27mar2018.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Visual resrv sample eval desc.: the visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.(b)(4) retain sample inspection form documented the retain evaluation performed.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety requested investigation requiring an investigation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Follow-up (25oct2018): new information from a contactable consumer includes: suspect product trade name, indication, additional lot number and expiration date, event description and outcome.Follow-up (06mar2019): new information received from a contactable consumer includes: patient group, device start date, action taken, event onset date.Added new events "burnt skin/they burn your skin", "had some dark spots from the product/ red spots/ the spots have turned very dark/ dark spots on either side of lower spine" and "skin is sensitive".The consumer was not hospitalized and did not receive any treatment for the event skin discoloration.Follow-up (27may2019): follow-up attempts are completed.No further information is expected.Follow-up (08aug2019): new information received from a product quality complaint group included: investigation results.Follow-up (14aug2019 and 11sep2019): new information received from a product quality complaint group included: severity of harm and investigation results.Follow-up (25oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events thermal burn, macule, skin discolouration and sensitive skin as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events thermal burn, macule, skin discolouration and sensitive skin as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burnt skin/they burn your skin [thermal burn], had some dark spots from the product/ red spots/ the spots have turned very dark/ dark spots on either side of lower spine [macule], skin discoloration/ skin on her back is a different color now/ spots on her skin are really dark [skin discolouration], skin is sensitive [sensitive skin].Narrative: this is a spontaneous report from a contactable consumer.An elderly female consumer started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) lot number w24915, lot number 202259 and expiry date: 31mar2021, from unknown date "for a long time" 4-5 years before (from 2014 to 2015) as it really helped with pain in her back/lower back pain.Medical history was not reported.There were no concomitant medications.Consumer had some dark spots from the product, and she asked will her skin discoloration go back to normal.She did wear the wrap over a layer of clothing.She had used thermacare long term, and she was sure her doctor wouldn't know what this was.She couldn't find the product in stores, her pharmacist told her they are recalled, so she ordered more from (website).She had red spots after wearing the wraps, but now the spots have turned very dark.The patient reports the skin on her back is a different color now and spots on her skin are really dark.She didn't wear them daily, just occasionally when her back goes out.She wanted to get rid of the spots and pfizer should know how to get rid of the spots.She thought the recall was more than what you were explaining.Upon follow up on (b)(6)2019, the consumer further reported that skin discoloration (still there) started 4-5 years (from 2014 or 2015).Left with the sensitivity on lower back on spots.She doesn't feel the spots will ever leave nor with the sense of feeling on spots.Burnt skin.When probed udi number, she said, "to many and never kept boxes or wraps they came but they burn your skin.Skin is sensitive." she also reported, "i wish i never used them- dark spots on either side of lower spine - should be able to sue for marks sensation when touching the marks.Bad item." the consumer was not hospitalized and did not receive any treatment for the event skin discoloration.The action taken in response to the event of the product was permanently withdrawn on an unspecified date.The outcome of the event skin discoloration was not recovered.The outcome of other events was unknown.Additional information received from product quality complaint (pqc) group included conclusion: 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 adverse event safety report for investigation.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 01mar2016 through 05331/2019/manufacturing site: pfizer (name)/complaint class: external cause.Investigation/complaint sub class: adverse event safety report for investigation.The citi search returned a total of 36 complaints for joint therapy 8 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety report for investigation.A citi complaint trend search was conducted for the subclass adverse event safety report for investigation for joint therapy 8 hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety report for investigation for joint therapy 8hr products, refer to the attached trend chart for mar2016 - mar2019.There is no further action required.Severity of harm: s3.Additional information received from product quality complaint (pqc) group included conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return samples received at the site were not associated with lot number w24915.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wraps caused "the skin because of the discoloration she has experienced." the cause of the discoloration received by the consumer is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Document review summary: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the device history record (dhr) for this lot concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this lot indicates that all required in process inspections were performed and all inspection criteria were met.There were no attribute or variable defects recorded for the lot.Thermal data for the lot shows all wraps met the required wrap lot average temperatures (37.6°c - 41.6°c) per (b)(4), effective: 27mar2018.This dhr has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving wrap temperatures.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend actions taken: based on this citi customizable search, there is not a trend identified for the subclasses of adverse event/serious/unknown, for m&j products the data did not show an increase over time (24 months).Site sample status was received at the site on 11sep2019.Return sample evaluation: ten wraps - one wrap shows evidence of wear.No obvious defects.Nine wraps are inside sealed pouches.Ten pouches - 4 - (l) x25942 s 10/20 exp sep2021 14:36.Three pouches sealed, one pouch open - no obvious defects.3 - (l) x70537 s 08/17 exp jul2021 13:44.All pouches sealed - no obvious defects.3 - (l) ak5122 n 01/19 exp dec2021 22:53.Note from consumer "what about all the 100's i used that burnt my back? they are gone.I would need a huge box to put them all in.Most of these are dead no heat." note: none of the above wraps received are associated to the lot number w24915 in this complaint investigation.Follow-up (25oct2018): new information from a contactable consumer includes: suspect product trade name, indication, additional lot number and expiration date, event description and outcome.Follow-up (06mar2019): new information received from a contactable consumer includes: patient group, device start date, action taken, event onset date.Added new events "burnt skin/they burn your skin", "had some dark spots from the product/ red spots/ the spots have turned very dark/ dark spots on either side of lower spine" and "skin is sensitive".The consumer was not hospitalized and did not receive any treatment for the event skin discoloration.Follow-up (27may2019): follow-up attempts are completed.No further information is expected.Follow-up (08aug2019): new information received from a product quality complaint group included: investigation results.Follow-up (14aug2019 and 11sep2019): new information received from a product quality complaint group included: severity of harm and investigation results.Follow-up (25oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (18sep2020): new information received from a product quality complaint group included: updated investigation results (return sample evaluation), expiry date and additional new information "most of these are dead no heat".Follow-up attempts are completed.No further information is expected.
|
| |
|
Manufacturer Narrative
|
|
Conclusion: 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 adverse event safety report for investigation.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 01mar2016 through 05331/2019/manufacturing site: pfizer (name)/complaint class: external cause.Investigation/complaint sub class: adverse event safety report for investigation.The citi search returned a total of 36 complaints for joint therapy 8 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety report for investigation.A citi complaint trend search was conducted for the subclass adverse event safety report for investigation for joint therapy 8 hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety report for investigation for joint therapy 8hr products, refer to the attached trend chart for mar2016 - mar2019.There is no further action required.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return samples received at the site were not associated with lot number w24915.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wraps caused "the skin because of the discoloration she has experienced." the cause of the discoloration received by the consumer is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Document review summary: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the device history record (dhr) for this lot concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this lot indicates that all required in process inspections were performed and all inspection criteria were met.There were no attribute or variable defects recorded for the lot.Thermal data for the lot shows all wraps met the required wrap lot average temperatures (37.6°c - 41.6°c) per spec-22096, effective: 27mar2018.This dhr has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving wrap temperatures.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend actions taken: based on this citi customizable search, there is not a trend identified for the subclasses of adverse event/serious/unknown, for m&j products the data did not show an increase over time (24 months).Site sample status was received at the site on 11sep2019.Return sample evaluation: ten wraps - one wrap shows evidence of wear.No obvious defects.Nine wraps are inside sealed pouches.Ten pouches - 4 - (l) x25942 s 10/20 exp sep2021 14:36.Three pouches sealed, one pouch open - no obvious defects.3 - (l) x70537 s 08/17 exp jul2021 13:44.All pouches sealed - no obvious defects.3 - (l) ak5122 n 01/19 exp dec2021 22:53.Note from consumer "what about all the 100's i used that burnt my back? they are gone.I would need a huge box to put them all in.Most of these are dead no heat." note: none of the above wraps received are associated to the lot number w24915 in this complaint investigation.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] burnt skin/they burn your skin [thermal burn], had some dark spots from the product/ red spots/ the spots have turned very dark/ dark spots on either side of lower spine [macule], skin discoloration/ skin on her back is a different color now/ spots on her skin are really dark [skin discolouration], skin is sensitive [sensitive skin], , narrative: this is a spontaneous report from a contactable consumer.An elderly female consumer started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) lot number w24915, lot number 202259 and expiry date: 31mar2021, from unknown date "for a long time" 4-5 years before (from 2014 to 2015) as it really helped with pain in her back/lower back pain.Medical history was not reported.There were no concomitant medications.Consumer had some dark spots from the product, and she asked will her skin discoloration go back to normal.She did wear the wrap over a layer of clothing.She had used thermacare long term, and she was sure her doctor wouldn't know what this was.She couldn't find the product in stores, her pharmacist told her they are recalled, so she ordered more from (website).She had had red spots after wearing the wraps, but now the spots have turned very dark.The patient reports the skin on her back is a different color now and spots on her skin are really dark.She didn't wear them daily, just occasionally when her back goes out.She wanted to get rid of the spots and pfizer should know how to get rid of the spots.She thought the recall was more than what you were explaining.Upon follow up on 06mar2019, the consumer further reported that skin discoloration (still there) started 4-5 years (from 2014 or 2015).Left with the sensitivity on lower back on spots.She doesn't feel the spots will ever leave nor with the sense of feeling on spots.Burnt skin.When probed udi number, she said, "to many and never kept boxes or wraps they came but they burn your skin.Skin is sensitive." she also reported, "i wish i never used them- dark spots on either side of lower spine - should be able to sue for marks sensation when touching the marks.Bad item." the consumer was not hospitalized and did not receive any treatment for the event skin discoloration.The action taken in response to the event of the product was permanently withdrawn on an unspecified date.The outcome of the event skin discoloration was not recovered.The outcome of other events was unknown.Additional information received from product quality complaint (pqc) group included conclusion: 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 adverse event safety report for investigation.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 01mar2016 through 05331/2019/manufacturing site: pfizer (name)/complaint class: external cause.Investigation/complaint sub class: adverse event safety report for investigation.The citi search returned a total of 36 complaints for joint therapy 8 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety report for investigation.A citi complaint trend search was conducted for the subclass adverse event safety report for investigation for joint therapy 8 hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety report for investigation for joint therapy 8hr products, refer to the attached trend chart for mar2016 - mar2019.There is no further action required.Severity of harm: s3.Additional information received from product quality complaint (pqc) group included conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return samples received at the site were not associated with lot number w24915.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wraps caused "the skin because of the discoloration she has experienced." the cause of the discoloration received by the consumer is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Document review summary: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the device history record (dhr) for this lot concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this lot indicates that all required in process inspections were performed and all inspection criteria were met.There were no attribute or variable defects recorded for the lot.Thermal data for the lot shows all wraps met the required wrap lot average temperatures (37.6°c - 41.6°c) per spec-22096, effective: 27mar2018.This dhr has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving wrap temperatures.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend actions taken: based on this citi customizable search, there is not a trend identified for the subclasses of adverse event/serious/unknown, for m&j products the data did not show an increase over time (24 months).Site sample status was received at the site on 11sep2019.Return sample evaluation: ten wraps - one wrap shows evidence of wear.No obvious defects.Nine wraps are inside sealed pouches.Ten pouches - 4 - (l) x25942 s 10/20 exp sep2021 14:36.Three pouches sealed, one pouch open - no obvious defects.3 - (l) x70537 s 08/17 exp jul2021 13:44.All pouches sealed - no obvious defects.3 - (l) ak5122 n 01/19 exp dec2021 22:53.Note from consumer "what about all the 100's i used that burnt my back? they are gone.I would need a huge box to put them all in.Most of these are dead no heat." note: none of the above wraps received are associated to the lot number w24915 in this complaint investigation.Additional information received from product quality complaint (pqc) group for complaint sub- class: wrap/patch/pad never worked/unusable/can not be reused.Summary is as follows: 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.Follow-up (25oct2018): new information from a contactable consumer includes: suspect product trade name, indication, additional lot number and expiration date, event description and outcome.Follow-up (06mar2019): new information received from a contactable consumer includes: patient group, device start date, action taken, event onset date.Added new events "burnt skin/they burn your skin", "had some dark spots from the product/ red spots/ the spots have turned very dark/ dark spots on either side of lower spine" and "skin is sensitive".The consumer was not hospitalized and did not receive any treatment for the event skin discoloration.Follow-up (27may2019): follow-up attempts are completed.No further information is expected.Follow-up (08aug2019): new information received from a product quality complaint group included: investigation results.Follow-up (14aug2019 and 11sep2019): new information received from a product quality complaint group included: severity of harm and investigation results.Follow-up (25oct2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up(18sep2020): new information received from a product quality complaint group included: updated investigation results (return sample evaluation), expiry date and additional new information "most of these are dead no heat".Follow-up attempts are completed.No further information is expected.Follow-up (12oct2020): new information received from a product quality complaint group included: investigation results.
|
| |
|
Manufacturer Narrative
|
|
Conclusion: 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 adverse event safety report for investigation.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.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) search was performed: scope: date contacted: 01mar2016 through 05331/2019/manufacturing site: pfizer (name)/complaint class: external cause.Investigation/complaint sub class: adverse event safety report for investigation.The citi search returned a total of 36 complaints for joint therapy 8 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety report for investigation.A citi complaint trend search was conducted for the subclass adverse event safety report for investigation for joint therapy 8 hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety report for investigation for joint therapy 8hr products, refer to the attached trend chart for mar2016 - mar2019.There is no further action required.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The return samples received at the site were not associated with lot number w24915.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wraps caused "the skin because of the discoloration she has experienced." the cause of the discoloration received by the consumer is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Document review summary: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the device history record (dhr) for this lot concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this lot indicates that all required in process inspections were performed and all inspection criteria were met.There were no attribute or variable defects recorded for the lot.Thermal data for the lot shows all wraps met the required wrap lot average temperatures (37.6°c - 41.6°c) per spec-22096, effective: 27mar2018.This dhr has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving wrap temperatures.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend actions taken: based on this citi customizable search, there is not a trend identified for the subclasses of adverse event/serious/unknown, for m&j products the data did not show an increase over time (24 months).Site sample status was received at the site on 11sep2019.Return sample evaluation: ten wraps - one wrap shows evidence of wear.No obvious defects.Nine wraps are inside sealed pouches.Ten pouches - 4 - (l) x25942 s 10/20 exp sep2021 14:36.Three pouches sealed, one pouch open - no obvious defects.3 - (l) x70537 s 08/17 exp jul2021 13:44.All pouches sealed - no obvious defects.3 - (l) ak5122 n 01/19 exp dec2021 22:53.Note from consumer "what about all the 100's i used that burnt my back? they are gone.I would need a huge box to put them all in.Most of these are dead no heat." note: none of the above wraps received are associated to the lot number w24915 in this complaint investigation.Additional information received from product quality complaint (pqc) group for complaint sub- class: wrap/patch/pad never worked/unusable/can not be reused.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.
|
| |
|
Search Alerts/Recalls
|
|
|
