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| Device Problems
Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911); Packaging Problem (3007)
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| Patient Problem
Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Manufacturer Narrative
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An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer (b)(4)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 274 complaints for lower back and hip products during this time period for the class/subclass.Of the 274 complaints; 37 complaints has the batch number recorded as "unknown".The 237 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products.The root cause category is non-assignable (not confirmed as a 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.There is not a trend identified for the subclass of adverse event for lbh products.The consumer reported receiving blisters after wearing the wrap.There is not a trend identified for the subclass of adverse event for lbh products.Adverse events for burns show peaks in november 2018 thru january2019."thermacare burn rate surveillance was inclu.".
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Event Description
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Event verbatim [preferred term] i got 2nd degree burns on my back/blisters [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for pain on back.Medical history and concomitant medications were not reported.Consumer stated "i used your product one time (one pad) and now have blisters all over the area where the pad was.I have a photo from my physician i can send to you.But this is unacceptable".As of 14mar2019, the patient stated "this was an item purchased at (pharmacy name) and not prescribed.A heating item to help pain on your back.I am a senior and i read the instructions, but missed were it said for anyone older than 55 to put over a layer of clothing.The print was so small that i could barely read it.I got 2nd degree burns on my back, the pain i was having has since been operated on and i'm pain free.I was stating that i thought it would be advisable for the company to make the print larger, as is something i wouldn't want anyone to have to go through".The action taken in response to the event of the product was unknown.The outcome of the event was unknown.According to product quality complaint, an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer (b)(4)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 274 complaints for lower back and hip products during this time period for the class/subclass.Of the 274 complaints; 37 complaints has the batch number recorded as "unknown".The 237 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products.The root cause category is non-assignable (not confirmed as a 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.There is not a trend identified for the subclass of adverse event for lbh products.The consumer reported receiving blisters after wearing the wrap.There is not a trend identified for the subclass of adverse event for lbh products.Adverse events for burns show peaks in november 2018 thru january2019.Thermacare burn rate surveillance was included in management review on 23jan2019.In the most recent 6 month period (jun-dec 2018), the burn cases/million wraps continues to be very stable (b)(4).No trend; the burn rate is within ppm.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Follow-up (25feb2019): new information received from the product quality complaint group included investigational results.Follow-up: (14mar2019): new information received from a contactable consumer included: suspect product data (indication), new event (2nd degree burns on my back) and case upgraded to serious, reportable mdr.Company clinical evaluation comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] i got 2nd degree burns on my back/blisters/blisters all over the area where the pad was [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of unknown age started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown frequency for pain on back.Medical history and concomitant medications were not reported.The patient stated "i used your product one time (one pad) and now have blisters all over the area where the pad was.I have a photo from my physician i can send to you.But this is unacceptable".As of (b)(6) 2019, the patient stated "this was an item purchased at (pharmacy name) and not prescribed.A heating item to help pain on your back.I am a senior and i read the instructions, but missed were it said for anyone older than 55 to put over a layer of clothing.The print was so small that i could barely read it.I got 2nd degree burns on my back, the pain i was having has since been operated on and i'm pain free.I was stating that i thought it would be advisable for the company to make the print larger, as is something i wouldn't want anyone to have to go through." the action taken in response to the event of the product was unknown.The outcome of the event was unknown.According to the product quality complaint group on 25feb2019: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer albany/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of (b)(4) complaints for lower back and hip products during this time period for the class/subclass.Of the (b)(4) complaints; (b)(4) complaints has the batch number recorded as "unknown".The (b)(4) remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products, refer to attachment for adverse event lbh jan2016 - jan2019.The root cause category is non-assignable (not confirmed as a 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.There is not a trend identified for the subclass of adverse event for lbh products.The consumer reported receiving blisters after wearing the wrap.There is not a trend identified for the subclass of adverse event for lbh products, refer to attachment adverse event lbh jan2016 - jan2019 trending graph.Adverse events for burns show peaks in november 2018 thru january2019.Thermacare burn rate surveillance was included in management review on 23jan2019.In the most recent 6 month period (jun-dec 2018), the burn cases/million wraps continues to be very stable at 3.61 less than maximum [<10].No trend; the burn rate is within ppm.According to the product quality complaint group on 28may2019: initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: site notification date: 01apr2016 through 01apr2016 manufacturing site: pfizer (city name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of (b)(4) complaints for lower back and hip 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 request for investigation.The adverse events complaint subclass show an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure #, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, refer to the attached trend chart for apr2016 - apr2019.There is no further action required.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 adverse event safety request 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.Follow-up (25feb2019): new information received from the product quality complaint group included investigational results.Follow-up (14mar2019): new information received from a contactable consumer included: suspect product data (indication), new event (2nd degree burns on my back) and case upgraded to serious, reportable mdr.Follow-up (28may2019): new information received from the product quality complaint group includes investigational results.Company clinical evaluation comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event burns second degree as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer albany/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of (b)(4) complaints for lower back and hip products during this time period for the class/subclass.Of the (b)(4) complaints; (b)(4) complaints has the batch number recorded as "unknown".The (b)(4) remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products, refer to attachment for adverse event lbh jan2016 - jan2019.The root cause category is non-assignable (not confirmed as a 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.There is not a trend identified for the subclass of adverse event for lbh products.The consumer reported receiving blisters after wearing the wrap.There is not a trend identified for the subclass of adverse event for lbh products, refer to attachment adverse event lbh jan2016 - jan2019 trending graph.Adverse events for burns show peaks in november 2018 thru january2019.Thermacare burn rate surveillance was included.
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Event Description
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Event verbatim [preferred term] i got 2nd degree burns on my back/blisters/blisters all over the area where the pad was [burns second degree] , applied the lower back and hip heatwrap directly against the skin [device use error].Case narrative:this is a spontaneous report from a contactable consumer.A 79-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date at unknown frequency for pain on back.The patient's medical history was not reported.Concomitant medications were reported as none.The patient stated "i used your product one time (one pad) and now have blisters all over the area where the pad was.I have a photo from my physician i can send to you.But this is unacceptable".As of 14mar2019, the patient stated "this was an item purchased at (pharmacy name) and not prescribed.A heating item to help pain on your back.I am a senior and i read the instructions, but missed were it said for anyone older than 55 to put over a layer of clothing.The print was so small that i could barely read it.I got 2nd degree burns on my back, the pain i was having has since been operated on and i'm pain free.I was stating that i thought it would be advisable for the company to make the print larger, as is something i wouldn't want anyone to have to go through".The patient applied the lower back and hip heatwrap directly against the skin.Action taken in response to the event of the product was permanently withdrawn on an unspecified date.No therapeutic measures were taken and no hospitalization was required as a result of the events.Clinical outcome of the event burns second degree was resolved.Clinical outcome of the event device use error was unknown.According to the product quality complaint group on 25feb2019: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer albany/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 274 complaints for lower back and hip products during this time period for the class/subclass.Of the 274 complaints; 37 complaints has the batch number recorded as "unknown".The 237 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products, refer to attachment for adverse event lbh (b)(6) 2016 - (b)(6) 2019.The root cause category is non-assignable (not confirmed as a 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.There is not a trend identified for the subclass of adverse event for lbh products.The consumer reported receiving blisters after wearing the wrap.There is not a trend identified for the subclass of adverse event for lbh products, refer to attachment adverse event lbh (b)(6) 2016 - (b)(6) 2019 trending graph.Adverse events for burns show peaks in november 2018 thru january2019.Thermacare burn rate surveillance was included in management review on 23jan2019.In the most recent 6 month period (jun-dec 2018), the burn cases/million wraps continues to be very stable at 3.61 less than maximum [<10].No trend; the burn rate is within ppm.According to the product quality complaint group on 28may2019: initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: site notification date: 01apr2016 through 01apr2016 manufacturing site: pfizer (city name)/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 269 complaints for lower back and hip 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 request for investigation.The adverse events complaint subclass show an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure #, "case processing principles product quality complaint guidance", updated on 20aug2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, refer to the attached trend chart for apr2016 - apr2019.There is no further action required.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 adverse event safety request 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.Follow-up (25feb2019): new information received from the product quality complaint group included investigational results.Follow-up (14mar2019): new information received from a contactable consumer included: suspect product data (indication), new event (2nd degree burns on my back) and case upgraded to serious, reportable mdr.Follow-up (28may2019): new information received from the product quality complaint group includes investigational results.Follow up (01jul2019): new information received from a contactable consumer includes: patient details, action taken with the suspect product, no concomitant medication, reaction data (additional event device use error), event outcome, no therapeutic measures taken and no hospitalization required.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events applied the lower back and hip heatwrap directly against the skin and burns second degree 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.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.Product effect varies with each individual.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 applied the lower back and hip heatwrap directly against the skin and burns second degree 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.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.Product effect varies with each individual.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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An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer albany/complaint class: external cause investigation complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 274 complaints for lower back and hip products during this time period for the class/subclass.Of the 274 complaints; 37 complaints has the batch number recorded as "unknown".The 237 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse events safety request for investigation for lbh products.There is no further action required.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products, refer to attachment for adverse event lbh jan2016 - jan2019.The root cause category is non-assignable (not confirmed as a 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.There is not a trend identified for the subclass of adverse event for lbh products.The consumer reported receiving blisters after wearing the wrap.There is not a trend identified for the subclass of adverse event for lbh products, refer to attachment adverse event lbh jan2016 - jan2019 trending graph.Adverse events for burns show peaks in november 2018 thru january2019.Thermacare burn rate surveillance was inclu.
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Search Alerts/Recalls
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