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| Device Problem
Leak/Splash (1354)
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| Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No trend has been identified for lbh product for the subclass of cells damaged/leaking.The following complaint was received under the sub-class "damage/leakage".This is a potential device malfunction s3-skin burn- per # (site name).Severity numbers applied in the thermacare heat wrap rmp, effective: 28sep2018, version #.A site full investigation is in process, a photo of the return sample was received.A device malfunction has been identified.
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Event Description
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Event verbatim (preferred term) leaking the black ingredient from the seams (device leakage).Case narrative: this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer stated "i use your product on a monthly basis, as it is very helpful! however, in my last box, when i opened one to put it on, it was leaking the black ingredient from the seams.I have a photo if you wish to see".The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No trend has been identified for lbh product for the subclass of cells damaged/leaking.According to product quality complaint group: the following complaint was received under the sub-class "damage/leakage".This is a potential device malfunction s3-skin burn- per # (site name).Severity numbers applied in the thermacare heat wrap rmp, effective: 28sep2018, version #.A site full investigation is in process, a photo of the return sample was received.A device malfunction has been identified.Follow-up (24jan2019): new information received from a product quality complaint group included: investigation results.Follow-up (17jan2019): this follow-up report is being submitted as a non-serious, reportable medical device report.Additional information received on 29mar2019 from product quality complaints includes investigational results.Company clinical evaluation comment: the device malfunction has been confirmed.This malfunction has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The company is conducting a further review on this investigation, and additional follow-up will be reported when the evaluation is completed., comment: the device malfunction has been confirmed.This malfunction has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.The company is conducting a further review on this investigation, and additional follow-up will be reported when the evaluation is completed.
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Event Description
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Event verbatim [preferred term] leaking the black ingredient from the seams [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer stated "i use your product on a monthly basis, as it is very helpful! however, in my last box, when i opened one to put it on, it was leaking the black ingredient from the seams.I have a photo if you wish to see".The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No trend has been identified for lbh product for the subclass of cells damaged/leaking.According to product quality complaint group: the following complaint was received under the sub-class "damage/leakage".This is a potential device malfunction s3-skin burn- per # (site name).Severity numbers applied in the thermacare heat wrap rmp, effective 28sep2018, version #.A site full investigation is in process, a photo of the return sample was received.A device malfunction has been identified.According to product quality complaint group: 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: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer albany/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 72 complaints for menstrual products during this time period for the class/subclass.There were two complaints, #: (b)(4); batch t26693 and #: (b)(4); batch t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.Pr#-pa1: create an mwi for purging brine.Pr#-pa.Replace current brine manifold to dispensing plate supply lines.Pr#-pa.Implement hpm hourly inspection.Pr#-pa 4: complete evaluation of wrap size /determine need to increase the outside border of the wrap from 3mmto 5mm.Pr#-pa.Complete evaluation of brine solution detectability by the quality check camera's/coloring brine or uv absorber.Pr#-pa 6: update failure mode effective analysis rpt-39239 to reflect mitigation actions for "brine outside cell.Pr#-pa 7: identify & update all previous complaint investigations due to unsealed cells for the 4 batches investigation 2018-#-us/pr# was executed for menstrual & muscle joint usa products with a subclass of cells damaged/leaking.A leaking cell pack for batch t26691 was the cause of the event.After aqrt review, the event was confirmed and resulted in a recall for the following batches: t26691, t26693, t26686 and s68516.This current complaint does not include the subclass of cells damaged/leaking.The adverse event safety request for investigation complaint subclass shows an increase in november 2018 thru february 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on august 20, 2018 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 menstrual products, refer to the attached trend chart for mar2016 - mar2019.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.Based on the complaint narrative this represents a potential device malfunction.The severity ranking is s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective 28sep2018, version 1.0.A return sample was not received; a device malfunction cannot be confirmed.There is no further investigation or actions needed.Follow-up (24jan2019): new information received from a product quality complaint group included: investigation results.Follow-up (17jan2019): this follow-up report is being submitted as a non-serious, reportable medical device report.Additional information received on 29mar2019 from product quality complaints includes investigational results.Follow-up (24apr2019): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: the reported device leakage has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.There was limited device specific information provided, a device malfunction cannot be confirmed, 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: the reported device leakage has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.There was limited device specific information provided, a device malfunction cannot be confirmed, 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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The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No trend has been identified for lbh product for the subclass of cells damaged/leaking.The following complaint was received under the sub-class "damage/leakage".This is a potential device malfunction s3-skin burn- per # (site name).Severity numbers applied in the thermacare heat wrap rmp, effective 28sep2018, version #.A site full investigation is in process, a photo of the return sample was received.A device malfunction has been identified.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: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer albany/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 72 complaints for menstrual products during this time period for the class/subclass.There were two complaints, (b)(4); batch t26693 and #(b)(4); batch t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment - other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.Pr#-pa1: create an mwi for purging brine.Pr#-pa 2: replace current brine manifold to dispensing plate supply lines.Pr#-pa 3: implement hpm hourly inspection.Pr#-pa 4: complete evaluation of wrap size /determine need to increase the outside border of the wrap from 3mmto 5mm.
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Manufacturer Narrative
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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: date contacted: (b)(6) 2016 through (b)(6) 2019/manufacturing site: pfizer albany/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 72 complaints for menstrual products during this time period for the class/subclass.There were two complaints, #-us/pr-2089752; batch t26693 and #-us/pr-2387819; batch t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment - other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.Pr#-pa1: create an mwi for purging brine.Pr#-pa 2: replace current brine manifold to dispensing plate supply lines.Pr#-pa 3: implement hpm hourly inspection.Pr#-pa 4: complete evaluation of wrap size /determine need to increase the outside border of the wrap from 3mmto 5mm.Pr#-pa 5: complete evaluation of brine solution detectability by the quality check camera's/coloring brine or uv absorber.Pr#-pa 6: update failure mode effective analysis rpt-39239 to reflect mitigation actions for "brine outside cell.Pr#-pa 7: identify & update all previous complaint investigations due to unsealed cells for the 4 batches investigation 2018-#-us/pr# was executed for menstrual & muscle joint usa products with a subclass of cells damaged/leaking.A leaking cell pack for batch t26691 was the cause of the event.After aqrt review, the event was confirmed and resulted in a recall for the following batches: t26691, t26693, t26686 and s68516.This current complaint does not include the subclass of cells damaged/leaking.The adverse event safety request.
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Event Description
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Event verbatim [preferred term] leaking the black ingredient from the seams [device leakage], case narrative:this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer stated "i use your product on a monthly basis, as it is very helpful! however, in my last box, when i opened one to put it on, it was leaking the black ingredient from the seams.I have a photo if you wish to see".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 group: as of (b)(6) 2019, 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: date contacted: (b)(6) 2016 through (b)(6) 2019 manufacturing site: pfizer albany/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 72 complaints for menstrual products during this time period for the class/subclass.There were two complaints, (b)(4); batch t26693 and #-(b)(4); batch t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment - other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.Pr#-pa1: create an mwi for purging brine.Pr#-pa 2: replace current brine manifold to dispensing plate supply lines.Pr#-pa 3: implement hpm hourly inspection.Pr#-pa 4: complete evaluation of wrap size /determine need to increase the outside border of the wrap from 3mmto 5mm.Pr#-pa 5: complete evaluation of brine solution detectability by the quality check camera's/coloring brine or uv absorber.Pr#-pa 6: update failure mode effective analysis rpt-39239 to reflect mitigation actions for "brine outside cell.Pr#-pa 7: identify & update all previous complaint investigations due to unsealed cells for the 4 batches investigation 2018-#-us/pr# was executed for menstrual & muscle joint usa products with a subclass of cells damaged/leaking.A leaking cell pack for batch t26691 was the cause of the event.After aqrt review, the event was confirmed and resulted in a recall for the following batches: t26691, t26693, t26686 and s68516.This current complaint does not include the subclass of cells damaged/leaking.The adverse event safety request for investigation complaint subclass shows an increase in (b)(6) 2018 thru (b)(6) 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on (b)(6) 2018 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 menstrual products, refer to the attached trend chart for (b)(6) 2016 - (b)(6) 2019.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.Based on the complaint narrative this represents a potential device malfunction.The severity ranking is s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective (b)(6) 2018, version 1.0.A return sample was not received; a device malfunction cannot be confirmed.There is no further investigation or actions needed.As of (b)(6) 2019, summary of investigation: this investigation was conducted for an unknown lot number of menstrual 8 hour product.There was limited device specific information provided, no batch number was available.A photograph of the return sample was attached for evaluation, no wrap packaging was included with the photograph, no way to identify the batch number associated with this complaint.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.Conclusion: 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/serious/unknown.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.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832hazard analysis.Thermacare heat wrap product: 8 and 12 hour, effective (b)(6) 2019, version 5.0.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) customizable search was performed: scope: site notification date:(b)(6) 2016 through (b)(6) 2019/ manufacturing site: pfizer albany/complaint class: external cause investigation /complaint sub class: adverse event /serious/unknown.The citi search returned a total of 146 complaints for menstrual products during this time period for the class/subclass.Two were confirmed to have a manufacturing process root cause for a complaint of adverse event serious/unknown.(b)(4) and 2018-#us/pr-# - the root cause of both events is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.Capa 's - pr-#-mwi for purging brine, pr- # - brine manifold supply line connectors, pr-# - hpm hourly inspection, (b)(4)- need to increase border of the wrap, pr-# - brine solution detectability, pr-# - update fmea rpt-# and pr-# - identify and update all previous complaint investigations.All capa's are closed.The subclass adverse event shows an increase in (b)(6) 2018.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "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.The data shows a trend emerging for the subclass in (b)(6) 2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the cells damaged/leaking recall of batches #, #, # and # from (b)(6) 2018.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in (b)(6) 2019.Majority of these complaints were related to burns reported from the consumer.This is also observed in a review of the 36 month trend chart for this subclass.Based on this citi search, there is not a trend identified for the subclass of adverse events safety request for investigation.Refer to the 36 month trend chart attached from (b)(6) 2016 or (b)(6) 2019.There is no further action required.As of (b)(6) 2019, conclusion: this investigation was conducted for an unknown lot number of menstrual 8 hour product.There was limited device specific information provided, no batch number was available.A photograph of the return sample was attached for evaluation, no wrap packaging was included with the photograph, there is no way to identify the batch number associated with this complaint.There is not a product quality related trend identified for the subclass cells damaged/leaking.This investigation was conducted for an unknown lot number of lower back and hip product.There was limited device specific information provided, no batch number was available for evaluation.The physical sample received at the site did not include packing materials that would allow the batch to be identified.Without a batch reference number 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 cells damaged/leaking.Based on the visual inspection of the photograph attached to the complaint file the root cause is most likely related to (b)(4); root cause category is equipment/other with method as a contributory factor.No further investigation is required.Exped trend assmt.& rationale: 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) customizable search was performed: scope: date contacted: (b)(6) 2016 through (b)(6) 2019 /manufacturing site: pfizer albany/complaint class: complaint sub class: cells damaged/leaking.The citi search returned a total of 57 complaints for menstrual products during this time period for the subclass.The complaints were evaluated.There were 21 complaints confirmed to have a manufacturing process root cause for the complaint of cells damaged/leaking.There are 8 complaints related to batch t26691 and 10 complaints related to batch t26693.These batches were manufactured consecutively on m line.Investigation pr-2379610 for lots t26691, t26693, t26686 & s68516 menstrual & muscle joint us for cells damaged/leaking was conducted for the subclass of cell pack damage/leaking.These batches were reviewed at aqrt and the outcome was to recall the four batches (t26691, t26693, and t26686 & s68516).The complaints were evaluated to identify any potential trend.An evaluation of the 36 month trend chart did not show a significant increase over time.The data, analysis & trending team evaluated the complaints information during (b)(6) 2018.As a result no trend was identified since these batches are attributed to a specific time frame and a cause identified as equipment.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for menstrual product, refer to attachment unknown menstrual cells damaged leaking.There is no further action required.Follow-up (b)(6) 2019: new information received from a product quality complaint group included: investigation results.Follow-up (b)(6) 2019: this follow-up report is being submitted as a non-serious, reportable medical device report.Additional information received on (b)(6) 2019 from product quality complaints includes investigational results.Follow-up (b)(6) 2019: new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.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 includes investigational results.Follow-up (b)(6) 2019: new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: the reported device leakage has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.There was limited device specific information provided, a device malfunction cannot be confirmed, 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: the reported device leakage has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.There was limited device specific information provided, a device malfunction cannot be confirmed, 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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Event Description
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Event verbatim [preferred term] leaking the black ingredient from the seams [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer stated "i use your product on a monthly basis, as it is very helpful! however, in my last box, when i opened one to put it on, it was leaking the black ingredient from the seams.I have a photo if you wish to see".The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No trend has been identified for lbh product for the subclass of cells damaged/leaking.According to product quality complaint group: 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: date contacted: 01jan2016 through (b)(6) 2019/manufacturing site: pfizer albany/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 72 complaints for menstrual products during this time period for the class/subclass.There were two complaints, #-us/(b)(4); batch t26693 and #-us/(b)(4).; batch t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment - other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.Pr#-pa1: create an mwi for purging brine.Pr#-pa 2: replace current brine manifold to dispensing plate supply lines.Pr#-pa 3: implement hpm hourly inspection.Pr#-pa 4: complete evaluation of wrap size /determine need to increase the outside border of the wrap from 3mmto 5mm.Pr#-pa 5: complete evaluation of brine solution detectability by the quality check camera's/coloring brine or uv absorber.Pr#-pa 6: update failure mode effective analysis rpt-39239 to reflect mitigation actions for "brine outside cell.Pr#-pa 7: identify & update all previous complaint investigations due to unsealed cells for the 4 batches investigation 2018-#-us/pr# was executed for menstrual & muscle joint usa products with a subclass of cells damaged/leaking.A leaking cell pack for batch t26691 was the cause of the event.After aqrt review, the event was confirmed and resulted in a recall for the following batches: t26691, t26693, t26686 and s68516.This current complaint does not include the subclass of cells damaged/leaking.The adverse event safety request for investigation complaint subclass shows an increase in november 2018 thru february 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "case processing principles product quality complaint guidance", updated on august 20, 2018 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 menstrual products, refer to the attached trend chart for mar2016 - mar2019.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.Based on the complaint narrative this represents a potential device malfunction.The severity ranking is s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective (b)(6) 2018, version 1.0.A return sample was not received; a device malfunction cannot be confirmed.There is no further investigation or actions needed.According to the product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number of menstrual 8 hour product.There was limited device specific information provided, no batch number was available.A photograph of the return sample was attached for evaluation, no wrap packaging was included with the photograph, no way to identify the batch number associated with this complaint.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.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: (b)(6) 2016 through (b)(6) 2016 /manufacturing site: pfizer (city name)/complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The citi search returned a total of 57 complaints for menstrual products during this time period for the subclass.The complaints were evaluated.There were 21 complaints confirmed to have a manufacturing process root cause for the complaint of cells damaged/leaking.The root cause and capa for the confirmed complaints are as follows: 2017-01-0002203-gc ((b)(4)., batch j23219 manufactured (b)(6) 2014), investigation (b)(4).Identified the root cause as method/document does not exist.There was not a manufacturing work instruction (mwi) that explains how to perform die-cutter re-adjustments during manufacturing.In addition, no procedure was identified that contains the instruction to open the cull station during die-cutter re-adjustments to ensure all produced wraps are rejected and do not move to the packaging portion of the manufacturing line.Commitment - 1087812 (sop - 79534 b-line/m-line - raw material die cutter calibration mwi) was closed on (b)(6) 2015 to address the die cutter calibration process.2017-01-0002205-gc ((b)(4), batch l44151 manufactured 12apr2015), identified the root cause as method/procedure category.Document is unclear or lacking detail.Although shifty cils were accomplished, which should remove excess glue build up in the vicinity of the web within the gawa, the overspray condition can occur at any time during production.There was no guidance for specific areas to be cleaned, periodicity of cleaning or visual management cues.Commitment - 1366258 was closed on (b)(6) 2016 to update the gawa cil document.2018-06-0034803-us ((b)(4) batch t65607 manufactured (b)(6) 2017) identified the root cause as equipment category, mechanical failure.Typically air in the line presents as either a shortage of brine being dosed to the cell or when the air discharges it can tend to blow some of the chemistry and brine mix out of the cell.The most probable cause is when the cell is dosed with brine, air in the line could splash chemistry out of the cell preventing the top and bottom sheets from sealing.The returned wrap pouch packaging date/time - was on (b)(6) 2017/20:39 hrs, south side.On (b)(6) 2017 day shift pump a40 was changed.This pump correlates to the adjacent cell to the leaking cell and aligns with the south side flow wrapper.Purge is a procedure to remove the air in the lines.Thermacare products manufacturing batch records indicate that if the line is down more than 2 hours purge for five minutes and if the line is down for more than 8 hours purge for fifteen minutes.However, there is no procedure and/or instructions that indicate purge the brine lines after a pump is changed.A visual aid need to be created to clearly indicate to purge the brine lines every time that a brine pump is calibrated, if the line is down more than 2 hours purge for five minutes and if the line is down for more than 8 hours purge for fifteen minutes.In addition there is was no preventive maintenance (pm) in place for the brine pumps at the time this batch was manufactured.Preventive maintenance (pm) is now in place for the brine pumps system.Also in-process attribute quality checks sampling frequency intervals were changed from every 10 minutes to every 6 minutes to help monitor the batch real-time and allow reaction to defect issues before the entire batch is processed.This change was implemented on (b)(6) 2018.2018-07-0044072-us ((b)(4)) and 2018-07-0047198-us ((b)(4).) are related to 2018-03-0016711-us ((b)(4)., batch t26693 manufactured (b)(6) 2017).Investigation (b)(4) determined the most probable root cause is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mis tracking issues.Sop-63921 equipment cleaning, inspection and lubrication (cil) procedure, was reviewed to delete the statement: "when timeallows, clean off." as this statement was not detailed enough and did not define periodicity of cleaning glue was able to build up and cause web to mistrack.2018-03-0014889-us (pr-2211120), 2018-04-0021368-us (pr-2231476), 2018-04-0021562-us ((b)(4)), 2018-06-0035694-us ((b)(4)), 2018-06-0038583-us ((b)(4).), 2018-10-0062009-us (2443071) and 2018-09-0060915-us ((b)(4).) are related to investigation (b)(4), batch t26691 manufactured (b)(6) 2017.(b)(4) determined the most probable root cause of the event is in the equipment category, other.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.2018-08-0049469-us (2379610) batch t26691 determined the root cause as equipment (tier 1) and other (tier 2) with method as a contributory factor.The most probable root cause is that a colleague inadvertently unseated the supply line from the connector to the dispensing plate as it was removed from the brine purge box and placed back onto the brine carriage after purging the brine.2017-11-0071835-us (pr-2074034), 2017-12-0076078-us ((b)(4)) and 2018-01-0006439-us ((b)(4).), 2018-02-0010652-us ((b)(4).), 2018-02-0014003-us ((b)(4).), 2018-04-0022238-us ((b)(4).), 2018-07-0047198-us ((b)(4).), 2018-11-0072110-us (2484408) are all related to investigation (b)(4)., batch t26693 manufactured (b)(6) 2017.(b)(4).Determined the most probable root cause of the event is in the equipment category, other.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.There are 8 complaints related to batch t26691 and 10 complaints related to batch t26693.These batches were manufactured consecutively on m line.The data, analysis & trending team evaluated the complaints information during may-june 2018.As a result no trend was identified since these batches are attributed to a specific time frame and a cause identified as equipment.Based on this pcom search for the subclass of cells damaged/leaking for menstrual products the data did not show an increase over time (36 months).There is not a trend identified for the subclass cell damaged/leaking for menstrual products, refer to attachment unknown menstrual-cells damaged.The complaints were evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 600 complaints was above the upper control limit (ucl) of 14 complaints per sop-105746 "complaint trending guideline", effective 05feb2019.An evaluation of the 36 month trend chart did not show a significant increase over time.Based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for\ menstrual product, refer to attachment menstrual heat cells damaged leaking.There is no further action required.Summary of investigation: this investigation was conducted for an unknown lot number menstrual 8 hour product.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/serious/unknown.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.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832hazard analysis.Thermacare heat wrap product: 8 and 12 hour, effective (b)(6) 2019, version 5.0.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) customizable search was performed: scope: site notification date:(b)(6) 2016 through (b)(6) 2019/ manufacturing site: pfizer albany/complaint class: external cause investigation /complaint sub class: adverse event /serious/unknown.The citi search returned a total of 146 complaints for menstrual products during this time period for the class/subclass.Two were confirmed to have a manufacturing process root cause for a complaint of adverse event serious/unknown.#-us/(b)(4).And 2018-#us/pr-# - the root cause of both events is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.Capa 's - pr-#-mwi for purging brine, pr- # - brine manifold supply line connectors, pr-# - hpm hourly inspection, (b)(4).- need to increase border of the wrap, pr-# - brine solution detectability, pr-# - update fmea rpt-# and pr-# - identify and update all previous complaint investigations.All capa's are closed.The subclass adverse event shows an increase in november 2018 thru december 2018.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "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.The data shows a trend emerging for the subclass in january thru (b)(6) 2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the cells damaged/leaking recall of batches #, #, # and # from (b)(6) 2018.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and (b)(6) 2019.Majority of these complaints were related to burns reported from the consumer.This is also observed in a review of the 36 month trend chart for this subclass.Based on this citi search, there is not a trend identified for the subclass of adverse events safety request for investigation.Refer to the 36 month trend chart attached from (b)(6) 2016 or (b)(6) 2019.There is no further action required.Follow-up ((b)(6) 2019): new information received from a product quality complaint group included: investigation results.Follow-up ((b)(6) 2019): this follow-up report is being submitted as a non-serious, reportable medical device report.Additional information received on (b)(6) 2019 from product quality complaints includes investigational results.Follow-up ((b)(6) 2019): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.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 includes investigational results.Company clinical evaluation comment: the reported device leakage has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.There was limited device specific information provided, a device malfunction cannot be confirmed, 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: the reported device leakage has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.There was limited device specific information provided, a device malfunction cannot be confirmed, 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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This investigation was conducted for an unknown lot number of menstrual 8 hour product.There was limited device specific information provided, no batch number was available.A photograph of the return sample was attached for evaluation, no wrap packaging was included with the photograph, no way to identify the batch number associated with this complaint.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.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: (b)(6) 2016 through (b)(6) 2016 /manufacturing site: pfizer (city name)/complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The citi search returned a total of 57 complaints for menstrual products during this time period for the subclass.The complaints were evaluated.There were 21 complaints confirmed to have a manufacturing process root cause for the complaint of cells damaged/leaking.The root cause and capa for the confirmed complaints are as follows: 2017-01-0002203-gc ((b)(4)., batch j23219 manufactured (b)(6) 2014), investigation (b)(4).Identified the root cause as method/document does not exist.There was not a manufacturing work instruction (mwi) that explains how to perform die-cutter re-adjustments during manufacturing.In addition, no procedure was identified that contains the instruction to open the cull station during die-cutter re-adjustments to ensure all produced wraps are rejected and do not move to the packaging portion of the manufacturing line.Commitment - 1087812 (sop - 79534 b-line/m-line - raw material die cutter calibration mwi) was closed on (b)(6) 2015 to address the die cutter calibration process.2017-01-0002205-gc ((b)(4), batch l44151 manufactured (b)(6) 2015), identified the root cause as method/procedure category.Document is unclear or lacking.
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Manufacturer Narrative
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The physical sample was not received at the site for evaluation.The photograph attached to the original complaint file (and to this investigation) shows a menstrual wrap with cell pack damage and leaking.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: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer albany/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 72 complaints for menstrual products during this time period for the class/subclass.There were two complaints, #-(b)(4); batch t26693 and #-(b)(4); batch t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment - other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.(b)(4): create an mwi for purging brine.(b)(4): replace current brine manifold to dispensing plate supply lines.(b)(4): implement hpm hourly inspection.(b)(4): complete evaluation of wrap size /determine need to increase the outside border of the wrap from 3mmto 5mm.(b)(4): complete evaluation of brine solution detectability by the quality check camera's/coloring brine or uv absorber.(b)(4): update failure mode effective analysis rpt-(b)(4) to reflect mitigation actions for "brine outside cell.(b)(4): identify & update all previous complaint investigations due to unsealed cells for the 4 batches investigation 2018-#-us/pr# was executed for menstrual & muscle joint usa products with a subclass of cells damaged/leaking.A leaking cell pack for batch t26691 was the cause of the event.After aqrt review, the event was con.
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Event Description
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Event verbatim [preferred term] leaking the black ingredient from the seams [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer stated "i use your product on a monthly basis, as it is very helpful! however, in my last box, when i opened one to put it on, it was leaking the black ingredient from the seams.I have a photo if you wish to see".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 group: as of 24apr2019, 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: date contacted: 01jan2016 through 31jan2019/manufacturing site: pfizer albany/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 72 complaints for menstrual products during this time period for the class/subclass.There were two complaints, (b)(4); batch t26693 and #-(b)(4); batch t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment - other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.(b)(4): create an mwi for purging brine.(b)(4): replace current brine manifold to dispensing plate supply lines.(b)(4): implement hpm hourly inspection.(b)(4): complete evaluation of wrap size /determine need to increase the outside border of the wrap from 3mmto 5mm.(b)(4): complete evaluation of brine solution detectability by the quality check camera's/coloring brine or uv absorber.(b)(4): update failure mode effective analysis rpt-39239 to reflect mitigation actions for "brine outside cell.(b)(4): identify & update all previous complaint investigations due to unsealed cells for the 4 batches investigation 2018-#-us/pr# was executed for menstrual & muscle joint usa products with a subclass of cells damaged/leaking.A leaking cell pack for batch t26691 was the cause of the event.After aqrt review, the event was confirmed and resulted in a recall for the following batches: t26691, t26693, t26686 and s68516.This current complaint does not include the subclass of cells damaged/leaking.The adverse event safety request for investigation complaint subclass shows an increase in november 2018 thru february 2019.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "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 menstrual products.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.Based on the complaint narrative this represents a potential device malfunction.The severity ranking is s3-skin burn- per rpt- # bridging pfizer hal severity numbers applied in the thermacare heat wrap rmp, effective 28sep2018, version 1.0.A return sample was not received; a device malfunction cannot be confirmed.There is no further investigation or actions needed.As of 20aug2019, summary of investigation: this investigation was conducted for an unknown lot number of menstrual 8 hour product.There was limited device specific information provided, no batch number was available.A photograph of the return sample was attached for evaluation, no wrap packaging was included with the photograph, no way to identify the batch number associated with this complaint.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.Conclusion: 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/serious/unknown.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.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832hazard analysis.Thermacare heat wrap product: 8 and 12 hour, effective 23-apr-2019, version 5.0.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) customizable search was performed: scope: site notification date:20aug2016 through 20aug2019/ manufacturing site: pfizer albany/complaint class: external cause investigation /complaint sub class: adverse event /serious/unknown.The citi search returned a total of 146 complaints for menstrual products during this time period for the class/subclass.Two were confirmed to have a manufacturing process root cause for a complaint of adverse event serious/unknown.#-(b)(4) and 2018-#us/pr-# - the root cause of both events is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.Capa 's - (b)(4) for purging brine, pr- # - brine manifold supply line connectors, pr-# - hpm hourly inspection, (b)(4) - need to increase border of the wrap, pr-# - brine solution detectability, pr-# - update fmea rpt-# and pr-# - identify and update all previous complaint investigations.All capa's are closed.The subclass adverse event shows an increase in november 2018 thru december 2018.This is a seasonality change in combination with a change in safety's procedure wsr cp001 wi 110, "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.The data shows a trend emerging for the subclass in january thru may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the cells damaged/leaking recall of batches #, #, # and # from sep2018.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.Majority of these complaints were related to burns reported from the consumer.This is also observed in a review of the 36 month trend chart for this subclass.Based on this citi search, there is not a trend identified for the subclass of adverse events safety request for investigation.There is no further action required.As of 18sep2019, conclusion: this investigation was conducted for an unknown lot number of menstrual 8 hour product.There was limited device specific information provided, no batch number was available.There is no way to identify the batch number associated with this complaint.There is not a product quality related trend identified for the subclass cells damaged/leaking.This investigation was conducted for an unknown lot number of lower back and hip product.There was limited device specific information provided, no batch number was available for evaluation.The physical sample received at the site did not include packing materials that would allow the batch to be identified.Without a batch reference number 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 cells damaged/leaking.Based on the visual inspection of the photograph attached to the complaint file the root cause is most likely related to (b)(4); root cause category is equipment/other with method as a contributory factor.No further investigation is required.Exped trend assmt.& rationale: 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) customizable search was performed: scope: date contacted: 18jan2016 through 18jan2019/manufacturing site: pfizer albany/complaint class: complaint sub class: cells damaged/leaking.The citi search returned a total of 57 complaints for menstrual products during this time period for the subclass.The complaints were evaluated.There were 21 complaints confirmed to have a manufacturing process root cause for the complaint of cells damaged/leaking.There are 8 complaints related to batch t26691 and 10 complaints related to batch t26693.These batches were manufactured consecutively on m line.Investigation (b)(4) for lots t26691, t26693, t26686 & s68516 menstrual & muscle joint us for cells damaged/leaking was conducted for the subclass of cell pack damage/leaking.These batches were reviewed at aqrt and the outcome was to recall the four batches (t26691, t26693, and t26686 & s68516).The complaints were evaluated to identify any potential trend.An evaluation of the 36 month trend chart did not show a significant increase over time.The data, analysis & trending team evaluated the complaints information during may-jun2018.As a result no trend was identified since these batches are attributed to a specific time frame and a cause identified as equipment.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of heat cells damaged/leaking for menstrual product, refer to attachment unknown menstrual cells damaged leaking.There is no further action required.On 17feb2020, product quality complaints provided the following return sample evaluation: the physical sample was not received at the site for evaluation.The photograph attached to the original complaint file (and to this investigation) shows a menstrual wrap with cell pack damage and leaking.Follow-up (24jan2019): new information received from a product quality complaint group included: investigation results.Follow-up (17jan2019): this follow-up report is being submitted as a non-serious, reportable medical device report.Additional information received on 29mar2019 from product quality complaints includes investigational results.Follow-up (24apr2019): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (12aug2019): follow-up attempts are completed.No further information is expected.Follow-up (20aug2019): new information received from the product quality complaint group includes investigational results.Follow-up (18sep2019): new information received from a product quality complaint group included: investigation results.Follow-up (17feb2020): new information received from a product quality complaint group includes: return sample evaluation (photographs).Follow-up attempts are completed.No further information is expected., comment: the reported device leakage has been identified prior to use of the device and the consumer did not use the device.No adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.There was limited device specific information provided, a device malfunction cannot be confirmed, 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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Search Alerts/Recalls
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