MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MUSCLE & JOINT; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE MUSCLE & JOINT; DISPOSABLE PACK, HOT

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Lot Number W24915

Device Problems Patient-Device Incompatibility (2682); Physical Resistance/Sticking (4012)

Patient Problems Abrasion (1689); Pain (1994); Blood Loss (2597)

Event Date 03/07/2018

Event Type Injury

Event Description

Event verbatim [preferred term] she was bleeding [haemorrhage] , ripped his mom's skins right off [skin exfoliation] , showering hurt the area on his mother and made it more painful [pain] , the adhesive is way too strong [device adhesion issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for his mother.A 60-year-old female patient started to receive thermacare heatwrap (thermacare muscle & joint), device lot number w24915, expiration date mar2021, upc number: 305733013038, from an unspecified date at 1 heatwrap applied to her shoulder area in the back for shoulder pain.There were no medical history and concomitant medications.The consumer reported that he and his mother have been using the product for years.He reported that the adhesive was way too strong and said that it ripped his mom's skin right off and she was bleeding on (b)(6) 2018.He said that he had pictures of the site.He reported that showering hurt the area on his mother and made it more painful.She was treating the affected area by keeping it clean and using neosporin.No lab data was provided.The consumer reported seriousness criteria as malfunction.The glue was way too strong.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was resolving.The consumer considered the events ripped her skin right off and she was bleeding were related to the device.Packaging was sealed and intact.Device was available for evaluation.The reporting nurse stated the patient did not provide information regarding the reported adverse events with the use of the product.According to the product quality complaint group: subclass: adverse event safety request for investigation.Sample status: received-site.Initial complaint assessment: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class adhesion/fastening defect requiring an investigation for this batch.The previous two complaints were not confirmed to have a manufacturing related root cause for the complaint.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 30 was below the upper control limit (ucl) of 189 complaints per sop-105746 "complaint trending guideline," effective 05feb2019.On the basis of this evaluation, a trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no attribute or variable defects recorded for the batch.The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.The material records for neck shoulder wrist/muscle and joint skin contact adhesive laminate 679mm; material number r000006147 (sca) were reviewed.There was one batch of sca used in the manufacturing of this batch, batch 2000977307.There were no supplier incident forms completed for this batch of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap adhesion.Retain sample evaluation desc: the visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 23apr2019 for an unrelated complaint.Document review summary: the review of the manufacturing attributes and variables quality checks, review of sca laminate used in the manufacturing of the batch.Return sample information: sample information?: received - site.Sample evaluation: two wraps - two wraps are inside completely sealed pouches.Opened pouches to inspect the skin contact adhesive material (sca) on the wraps returned.There were no obvious defects associated with the sca.The wraps are missing the glue that combines the body side non woven material to the cell pack.Investigation (b)(4) for came apart/separated/torn (excludes damaged cells) will be completed by technical services to determine a root cause of the glue missing.Two pouches - (l) w24915 n 04/20, exp mar2021 01:28, one carton - (l) w24915 4/20, exp mar2021 01:29, carton is open.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The return sample shows the wraps are missing the glue that combines the body side non woven material to the cell pack.Non pcom complaint - investigation (b)(4) for came apart/separated/torn (excludes damaged cells) is being completed by technical services to investigate the results of the return sample evaluation showing the wraps missing glue that combines the body side non woven material to the cell pack.This missing glue will affect the skin contact adhesive or cause adhesive to rip the skin; the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.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.Process related?: no.Complaint confirmed?: no.Design related?: no.Notify safety?: no.Follow-up (07may2019): new information received from a contactable other health professional includes additional reporter information.Follow up (29may2019): new information received from the product quality complaint group included investigational results.Follow-up (28may2019): new information received from a contactable nurse includes additional reporter information.Company clinical evaluation comment: based on the information provided, the events of "she was bleeding", "ripped his mom's skins right off", "showering hurt the area on his mother and made it more painful" and "the adhesive is way too strong" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "she was bleeding", "ripped his mom's skins right off", "showering hurt the area on his mother and made it more painful" and "the adhesive is way too strong" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Subclass: adverse event safety request for investigation.Sample status: received -site.Initial complaint assessment: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 on 23apr2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class adhesion/fastening defect requiring an investigation for this batch.The previous two complaints were not confirmed to have a manufacturing related root cause for the complaint.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of (b)(4) was below the upper control limit (ucl) of 189 complaints per (b)(4)"complaint trending guideline," effective 05feb2019.On the basis of this evaluation, a trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no attribute or variable defects recorded for the batch.The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.The material records for neck shoulder wrist/muscle and joint skin contact adhesive laminate 679mm; material number r000006147 (sca) were reviewed.There was one batch of sca used in the manufacturing of this batch, batch 2000977307.There were no supplier incident forms completed for this batch of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.

Event Description

Event verbatim [preferred term] she was bleeding [haemorrhage] , ripped his mom's skins right off [skin exfoliation] , showering hurt the area on his mother and made it more painful [pain] , the adhesive is way too strong [device adhesion issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for his mother.A 60-year-old female patient started to receive thermacare heatwrap (thermacare muscle & joint), device lot number w24915, expiration date mar2021, upc number: 305733013038, from an unspecified date at 1 heatwrap applied to her shoulder area in the back for shoulder pain.There were no medical history and concomitant medications.The consumer reported that he and his mother have been using the product for years.He reported that the adhesive was way too strong and said that it ripped his mom's skin right off and she was bleeding on (b)(6) 2018.He said that he had pictures of the site.He reported that showering hurt the area on his mother and made it more painful.She was treating the affected area by keeping it clean and using neosporin.No lab data was provided.The consumer reported seriousness criteria as malfunction.The glue was way too strong.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was resolving.The consumer considered the events ripped her skin right off and she was bleeding were related to the device.Packaging was sealed and intact.Device was available for evaluation.According to the product quality complaint group: subclass: adverse event safety request for investigation.Sample status: received-site.Initial complaint assessment: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class adhesion/fastening defect requiring an investigation for this batch.The previous two complaints were not confirmed to have a manufacturing related root cause for the complaint.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 30 was below the upper control limit (ucl) of 189 complaints per sop-105746 "complaint trending guideline," effective (b)(6) 2019.On the basis of this evaluation, a trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no attribute or variable defects recorded for the batch.The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.The material records for neck shoulder wrist/muscle and joint skin contact adhesive laminate 679mm; material number r000006147 (sca) were reviewed.There was one batch of sca used in the manufacturing of this batch, batch 2000977307.There were no supplier incident forms completed for this batch of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap adhesion.Retain sample evaluation desc: the visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b(6) 2019 for an unrelated complaint.Document review summary: the review of the manufacturing attributes and variables quality checks, review of sca laminate used in the manufacturing of the batch.Return sample information: sample information?: received - site.Sample evaluation: two wraps - two wraps are inside completely sealed pouches.Opened pouches to inspect the skin contact adhesive material (sca) on the wraps returned.There were no obvious defects associated with the sca.The wraps are missing the glue that combines the body side non woven material to the cell pack.Investigation pr-2702000 for came apart/separated/torn (excludes damaged cells) will be completed by technical services to determine a root cause of the glue missing.Two pouches - (l) w24915 n 04/20, exp mar2021 01:28, one carton - (l) w24915 04/20, exp mar2021 01:29, carton is open.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The return sample shows the wraps are missing the glue that combines the body side non woven material to the cell pack.Non pcom complaint - investigation pr-2702000 for came apart/separated/torn (excludes damaged cells) is being completed by technical services to investigate the results of the return sample evaluation showing the wraps missing glue that combines the body side non woven material to the cell pack.This missing glue will affect the skin contact adhesive or cause adhesive to rip the skin; the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.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.Process related?: no.Complaint confirmed?: no.Design related?: no.Notify safety?: no.Follow-up ((b)(6) 2019): new information received from a contactable other health professional includes additional reporter information.Follow up ((b)(6)2019): new information received from the product quality complaint group included investigational results.Company clinical evaluation comment: based on the information provided, the events of "she was bleeding", "ripped his mom's skins right off", "showering hurt the area on his mother and made it more painful" and "the adhesive is way too strong" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "she was bleeding", "ripped his mom's skins right off", "showering hurt the area on his mother and made it more painful" and "the adhesive is way too strong" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Subclass: adverse event safety request for investigation.Sample status: received -site.Initial complaint assessment: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class adhesion/fastening defect requiring an investigation for this batch.The previous two complaints were not confirmed to have a manufacturing related root cause for the complaint.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 30 was below the upper control limit (ucl) of 189 complaints per sop-105746 "complaint trending guideline," effective 05feb2019.On the basis of this evaluation, a trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no attribute or variable defects recorded for the batch.The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non woven materials together, including applying the tape that attaches the wrap to the body.The material records for neck shoulder wrist/muscle and joint skin contact adhesive laminate 679mm; material number r000006147 (sca) were reviewed.There was one batch of sca used in the manufacturing of this batch, batch 2000977307.There were no supplier incident forms completed for this batch of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch has been reviewed from a manufacturing perspective.

Event Description

Event verbatim [preferred term] she was bleeding [haemorrhage] , ripped his mom's skins right off [skin exfoliation] , showering hurt the area on his mother and made it more painful [pain] , the adhesive is way too strong [device adhesion issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for his mother.A 60-year-old female patient started to receive thermacare heatwrap (thermacare muscle & joint), device lot number w24915, expiration date mar2021, upc number: 305733013038, from an unspecified date at 1 heatwrap applied to her shoulder area in the back for shoulder pain.There were no medical history and concomitant medications.The consumer reported that he and his mother have been using the product for years.He reported that the adhesive was way too strong and said that it ripped his mom's skin right off and she was bleeding on (b)(6) 2018.He said that he had pictures of the site.He reported that showering hurt the area on his mother and made it more painful.She was treating the affected area by keeping it clean and using neosporin.No lab data was provided.The consumer reported seriousness criteria as malfunction.The glue was way too strong.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was resolving.The consumer considered the events ripped her skin right off and she was bleeding were related to the device.Packaging was sealed and intact.Device was available for evaluation.The reporting nurse stated the patient did not provide information regarding the reported adverse events with the use of the product.According to the product quality complaint group: subclass: adverse event safety request for investigation.Sample status: received-site.Initial complaint assessment: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class adhesion/fastening defect requiring an investigation for this batch.The previous two complaints were not confirmed to have a manufacturing related root cause for the complaint.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 30 was below the upper control limit (ucl) of 189 complaints per sop-105746 "complaint trending guideline," effective 05feb2019.On the basis of this evaluation, a trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no 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 involving wrap adhesion.Document review summary: the review of the manufacturing attributes and variables quality checks, review of sca laminate used in the manufacturing of the batch.Return sample information: sample information?: received - site.Sample evaluation: two wraps - two wraps are inside completely sealed pouches.Opened pouches to inspect the skin contact adhesive material (sca) on the wraps returned.There were no obvious defects associated with the sca.The wraps are missing the glue that combines the body side non woven material to the cell pack.Investigation pr-2702000 for came apart/separated/torn (excludes damaged cells) will be completed by technical services to determine a root cause of the glue missing.Two pouches - (l) w24915 n 04/20, exp mar2021 01:28, one carton - (l) w24915 04/20, exp mar2021 01:29, carton is open.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The return sample shows the wraps are missing the glue that combines the body side non woven material to the cell pack.Non pcom complaint - investigation pr-2702000 for came apart/separated/torn (excludes damaged cells) is being completed by technical services to investigate the results of the return sample evaluation showing the wraps missing glue that combines the body side non woven material to the cell pack.This missing glue will affect the skin contact adhesive or cause adhesive to rip the skin; the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.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.Severity of harm: s3.Follow-up (07may2019): new information received from a contactable other health professional includes additional reporter information.Follow up (29may2019): new information received from the product quality complaint group included investigational results.Follow-up (28may2019): new information received from a contactable nurse includes additional reporter information.Follow-up (b)(6) 2019: follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2019): new information received from the product quality complaint group included severity of harm.Company clinical evaluation comment: based on the information provided, the events of "she was bleeding", "ripped his mom's skins right off", "showering hurt the area on his mother and made it more painful" and "the adhesive is way too strong" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "she was bleeding", "ripped his mom's skins right off", "showering hurt the area on his mother and made it more painful" and "the adhesive is way too strong" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Subclass: adverse event safety request for investigation.Sample status: received-site.Initial complaint assessment: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6).2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class adhesion/fastening defect requiring an investigation for this batch.The previous two complaints were not confirmed to have a manufacturing related root cause for the complaint.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 30 was below the upper control limit (ucl) of 189 complaints per (b)(4) "complaint trending guideline," effective (b)(6) 2019.On the basis of this evaluation, a trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no 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 involving wrap adhesion.Document review summary: the review of the manufacturing attributes and variables quality checks, review of sca laminate used in the manufacturing of the batch.Return sample information: sample information?: received - site.Sample evaluation: two wraps - two wraps are inside completely sealed pouches.Opened pouches to inspect the skin contact adhesive material (sca) on the wraps returned.There were no obvious defects associated with the sca.The wraps are missing the gl.

Manufacturer Narrative

Subclass: adverse event safety request for investigation.Sample status: received-site.Initial complaint assessment: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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 on (b)(6) 2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class adhesion/fastening defect requiring an investigation for this batch.The previous two complaints were not confirmed to have a manufacturing related root cause for the complaint.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 30 was below the upper control limit (ucl) of 189 complaints per sop-105746 "complaint trending guideline," effective (b)(6) 2019.On the basis of this evaluation, a trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no 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 involving wrap adhesion.Document review summary: the review of the manufacturing attributes and variables quality checks, review of sca laminate used in the manufacturing of the batch.Return sample information: sample information?: received - site.Sample evaluation: two wraps - two wraps are inside completely sealed pouches.Opened pouches to inspect the skin contact adhesive material (sca) on the wraps returned.There were no obvious defects associated with the sca.The wraps are missing the gl.

Event Description

Event verbatim [preferred term] she was bleeding [haemorrhage] , ripped his mom's skins right off [skin exfoliation] , showering hurt the area on his mother and made it more painful [pain] , the adhesive is way too strong [device adhesion issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for his mother.A 60-year-old female patient started to receive thermacare heatwrap (thermacare muscle & joint), device lot number w24915, expiration date mar2021, upc number: 305733013038, from an unspecified date at 1 heatwrap applied to her shoulder area in the back for shoulder pain.There were no medical history and concomitant medications.The consumer reported that he and his mother have been using the product for years.He reported that the adhesive was way too strong and said that it ripped his mom's skin right off and she was bleeding on (b)(6) 2018.He said that he had pictures of the site.He reported that showering hurt the area on his mother and made it more painful.She was treating the affected area by keeping it clean and using neosporin.No lab data was provided.The consumer reported seriousness criteria as malfunction.The glue was way too strong.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was resolving.The consumer considered the events ripped her skin right off and she was bleeding were related to the device.Packaging was sealed and intact.Device was available for evaluation.The reporting other health professional stated the patient did not provide information regarding the reported adverse events with the use of the product.According to the product quality complaint group: subclass: adverse event safety request for investigation.Sample status: received-site.Initial complaint assessment: batch w24915 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2019 for an unrelated complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class adhesion/fastening defect requiring an investigation for this batch.The previous two complaints were not confirmed to have a manufacturing related root cause for the complaint.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 30 was below the upper control limit (ucl) of 189 complaints per sop-105746 "complaint trending guideline," effective (b)(6) 2019.On the basis of this evaluation, a trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no 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 involving wrap adhesion.Document review summary: the review of the manufacturing attributes and variables quality checks, review of sca laminate used in the manufacturing of the batch.Return sample information: sample information?: received - site.Sample evaluation: two wraps - two wraps are inside completely sealed pouches.Opened pouches to inspect the skin contact adhesive material (sca) on the wraps returned.There were no obvious defects associated with the sca.The wraps are missing the glue that combines the body side non woven material to the cell pack.Investigation (b)(4) for came apart/separated/torn (excludes damaged cells) will be completed by technical services to determine a root cause of the glue missing.Two pouches - (l) w24915 n 04/20, exp mar2021 01:28, one carton - (l) w24915 04/20, exp mar2021 01:29, carton is open.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The return sample shows the wraps are missing the glue that combines the body side non woven material to the cell pack.Non pcom complaint - investigation (b)(4) for came apart/separated/torn (excludes damaged cells) is being completed by technical services to investigate the results of the return sample evaluation showing the wraps missing glue that combines the body side non woven material to the cell pack.This missing glue will affect the skin contact adhesive or cause adhesive to rip the skin; the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.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.Severity of harm: s3.Follow-up (07may2019): new information received from a contactable other health professional includes additional reporter information.Follow up (29may2019): new information received from the product quality complaint group included investigational results.Follow-up (28may2019): new information received from a contactable other health professional includes additional reporter information.Follow-up (22jul2019): follow-up attempts are completed.No further information is expected.Follow-up (04nov2019): new information received from the product quality complaint group included severity of harm.Amendment: this follow-up report is being submitted to amend previously reported information: update reporter occupation.Company clinical evaluation comment: based on the information provided, the events of "she was bleeding", "ripped his mom's skins right off", "showering hurt the area on his mother and made it more painful" and "the adhesive is way too strong" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "she was bleeding", "ripped his mom's skins right off", "showering hurt the area on his mother and made it more painful" and "the adhesive is way too strong" as described are considered serious bodily injury 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

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Brand Name

THERMACARE MUSCLE & JOINT

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

8440960

MDR Text Key

139479137

Report Number

1066015-2019-00072

Device Sequence Number

Product Code

IMD

UDI-Device Identifier

00305733013038

UDI-Public

305733013038

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,health professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Lay User/Patient

Device Expiration Date

03/01/2021

Device Lot Number

W24915

Was Device Available for Evaluation?

Yes

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

03/21/2019

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided
Not provided
Not provided

Supplement Dates FDA Received

05/16/2019
06/04/2019
06/05/2019
11/14/2019
11/22/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

60 YR

Patient Weight

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MUSCLE & JOINT; DISPOSABLE PACK, HOT

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