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| Lot Number T26693 |
| Device Problems
Leak/Splash (1354); Nonstandard Device (1420); Unsealed Device Packaging (1444); Product Quality Problem (1506); Defective Device (2588)
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| Patient Problems
Burning Sensation (2146); Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.Our manufacturing operations employ quality control procedures which include in process 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.Investigation pr (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr (b)(4).
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Event Description
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Event verbatim [preferred term] it felt like slightly hot ambers were spread on my genitals [burning sensation], two wraps she opened so far have not been entirely sealed in one corner allowing the material inside to spill out [device leakage], the contents of three of the cells had overflowed slightly before it had been stuck to the backing so that the black material was spread through where the adhesive was [device issue].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual) (device lot number t26693, expiration date aug2020) from an unspecified date for menstrual pain and menstrual cramps.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported in the most recent package she purchased the two wraps she opened so far have not been entirely sealed in one corner allowing the material inside to spill out.She stated the wrap itself did not initially leak so she hadn't noticed the defect in it at first.But, if you looked at the wrap, you could see that the contents of three of the cells had overflowed slightly before it had been stuck to the backing so that the black material was spread through where the adhesive was.This prevented a complete seal.A seal around the outside edge held long enough for her to apply the wrap without noticing the defect.She then sat down for a while to rest.After about a half hour or so, it felt like slightly hot ambers were spread on her genitals.Those three cells had spilled out.The patient showered then got the next wrap out of the box, opened it, and saw the same type of defect.Four came in the box, she figured since the first two had that issue the next two probably did as well.The patient reported the outside packaging that you tear to activate the wrap was completely sealed.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group on 10jan2018: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process 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.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.According to the product quality complaint group on 24oct2018: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.Our manufacturing operations employ quality control procedures which include in process 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.Investigation pr (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr (b)(4).Follow-up (10jan2018): the initial case was missing the following minimum criteria: other-info not qualifying for ae reporting-product complaint.Upon receipt of follow-up information on 10jan2018 this case now contains all required information to be considered valid.New information received from product quality complaints (pqc) group included: product quality investigation results and reaction data (new event burning sensation).Follow-up (24oct2018): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.Comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process 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.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.According to the product quality complaint group on 24oct2018: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.Our manufacturing operations employ quality control procedures which include in process 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.Investigation (b)(4) menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).Investigation results reported on 24oct2018 were as follows: batch t26693 is the only batch within the scope of this investigation.Thermacare batches are produced as.
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Event Description
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Event verbatim [preferred term] it felt like slightly hot embers were spread on my genitals [thermal burn] , contents of three of the cells had overflowed slightly before it had been stuck to the backing so that the black material was spread through where the adhesive was/not been entirely sealed in 1 corner [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual) (device lot number t26693, expiration date aug2020) from an unspecified date for menstrual pain and menstrual cramps.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported in the most recent package she purchased the two wraps she opened so far have not been entirely sealed in one corner allowing the material inside to spill out.She stated the wrap itself did not initially leak so she hadn't noticed the defect in it at first.But, if you looked at the wrap, you could see that the contents of three of the cells had overflowed slightly before it had been stuck to the backing so that the black material was spread through where the adhesive was.This prevented a complete seal.A seal around the outside edge held long enough for her to apply the wrap without noticing the defect.She then sat down for a while to rest.After about a half hour or so, it felt like slightly hot embers were spread on her genitals.Those three cells had spilled out.The patient showered then got the next wrap out of the box, opened it, and saw the same type of defect.Four came in the box, she figured since the first two had that issue the next two probably did as well.The patient reported the outside packaging that you tear to activate the wrap was completely sealed.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group on 10jan2018: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process 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.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.According to the product quality complaint group on 24oct2018: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.Our manufacturing operations employ quality control procedures which include in process 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.Investigation (b)(4) menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).Investigation results reported on 24oct2018 were as follows: batch t26693 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included six cartons, 24 pouches and the 24 wraps inside.Inspection shows no obvious defects, to cartons, pouches or wraps.There were no cells damaged or leaking.Inspection form documented the retain evaluation performed on 20-nov-2017 for a previous complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class cells damaged/leaking requiring an investigation for this batch.A full investigation (b)(4) was completed for a previous complaint confirmed by return sample for cells damaged/leaking.The most probable root cause was identified as equipment - other.On the basis of this evaluation, a trend does not exist for this batch.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: 10jan2016 through 10jan2018/manufacturing site: (site name)/complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 13 complaints for menstrual products during this time period for the class/subclass.Of the 13 complaints; 5 complaints have batch number recorded as "unknown".The 8 remaining complaints were evaluated.One of the seven complaints was confirmed to have a manufacturing process root cause for a cell damage/leaking.Investigation # was completed for complaint # and 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 28aug2015 to address the die cutter calibration process.Based on this pcom search, there is not a trend identified for the subclass of cell damage/leaking for menstrual products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects for the batch.Shifty production transition notes were reviewed.There were no issues noted that would cause cells to be damaged or leaking.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.Our manufacturing operations employ quality control procedures which include in process 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.Investigation (b)(4) menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr # according to the product quality complaint group on 15nov2019, reasonably suggest device malfunction: yes, severity of harm was assessed as s3.Follow-up (10jan2018): the initial case was missing the following minimum criteria: other-info not qualifying for ae reporting-product complaint.Upon receipt of follow-up information on 10jan2018 this case now contains all required information to be considered valid.New information received from product quality complaints (pqc) group included: product quality investigation results and reaction data (new event burning sensation).Follow-up (24oct2018): new information received from product quality complaint group includes investigation results.Follow-up (28feb2019): follow-up attempts are completed.No further information is expected.Follow-up (24oct2018): new information reported from product quality complaints includes investigation report.Follow-up (15nov2019): new information reported from product quality complaints includes: malfunction assessment and severity of harm.Company clinical evaluation comment the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process 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.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.According to the product quality complaint group on 24oct2018: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.Our manufacturing operations employ quality control procedures which include in process 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.Investigation pr (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr (b)(4).Investigation results reported on 24oct2018 were as follows: batch t26693 is the only batch within the scope of this investigation.Thermacare batches are produced as.
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Event Description
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Event verbatim [preferred term] it felt like slightly hot ambers were spread on my genitals [thermal burn] , contents of three of the cells had overflowed slightly before it had been stuck to the backing so that the black material was spread through where the adhesive was/not been entirely sealed in 1 corner [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual) (device lot number t26693, expiration date aug2020) from an unspecified date for menstrual pain and menstrual cramps.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported in the most recent package she purchased the two wraps she opened so far have not been entirely sealed in one corner allowing the material inside to spill out.She stated the wrap itself did not initially leak so she hadn't noticed the defect in it at first.But, if you looked at the wrap, you could see that the contents of three of the cells had overflowed slightly before it had been stuck to the backing so that the black material was spread through where the adhesive was.This prevented a complete seal.A seal around the outside edge held long enough for her to apply the wrap without noticing the defect.She then sat down for a while to rest.After about a half hour or so, it felt like slightly hot ambers were spread on her genitals.Those three cells had spilled out.The patient showered then got the next wrap out of the box, opened it, and saw the same type of defect.Four came in the box, she figured since the first two had that issue the next two probably did as well.The patient reported the outside packaging that you tear to activate the wrap was completely sealed.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group on 10jan2018: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process 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.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.According to the product quality complaint group on 24oct2018: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.Our manufacturing operations employ quality control procedures which include in process 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.Investigation pr (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr (b)(4).Investigation results reported on 24oct2018 were as follows: batch t26693 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included six cartons, 24 pouches and the 24 wraps inside.Inspection shows no obvious defects, to cartons, pouches or wraps.There were no cells damaged or leaking.Inspection form documented the retain evaluation performed on 20-nov-2017 for a previous complaint.An evaluation of the complaint history confirms that this is the third complaint for the sub class cells damaged/leaking requiring an investigation for this batch.A full investigation (b)(4) was completed for a previous complaint confirmed by return sample for cells damaged/leaking.The most probable root cause was identified as equipment - other.On the basis of this evaluation, a trend does not exist for this batch.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: 10jan2016 through 10jan2018/manufacturing site: (site name)/complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 13 complaints for menstrual products during this time period for the class/subclass.Of the 13 complaints; 5 complaints have batch number recorded as "unknown".The 8 remaining complaints were evaluated.One of the seven complaints was confirmed to have a manufacturing process root cause for a cell damage/leaking.Investigation # was completed for complaint # and 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 28aug2015 to address the die cutter calibration process.Based on this pcom search, there is not a trend identified for the subclass of cell damage/leaking for menstrual products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects for the batch.Shiftly production transition notes were reviewed.There were no issues noted that would cause cells to be damaged or leaking.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).The sample has not been received from consumer for evaluation by the site, the complaint can not be confirmed.If the samples are received this investigation will be reopened and the results of the return sample evaluation will be added.Our manufacturing operations employ quality control procedures which include in process 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.Investigation pr (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr #.Follow-up (10jan2018): the initial case was missing the following minimum criteria: other-info not qualifying for ae reporting-product complaint.Upon receipt of follow-up information on 10jan2018 this case now contains all required information to be considered valid.New information received from product quality complaints (pqc) group included: product quality investigation results and reaction data (new event burning sensation).Follow-up (24oct2018): new information received from product quality complaint group includes investigation results.Follow-up (28feb2019): follow-up attempts are completed.No further information is expected.Follow-up (24oct2018): new information reported from product quality complaints includes investigation report.Company clinical evaluation comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
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Search Alerts/Recalls
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