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PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT
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| Lot Number AA2378 |
| Device Problems
Loss of or Failure to Bond (1068); Difficult to Remove (1528)
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| Patient Problem
Skin Irritation (2076)
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Event Type
Injury
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Event Description
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The other side gave me a water blister after i finally managed to peel it off [blister], one side didn't stay stuck on her skin for less than an hour and the other side gave her a water blister [device adhesion issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported "y'all need to equally distribute the adhesive or something", one side didn't stay stuck on her skin for less than an hour, she even made sure that her lower back was clean and no clothing got stuck in the adhesive, and the other side gave her a water blister after she finally managed to peel it off on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available.
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Event Description
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Event verbatim [preferred term], the other side gave me a water blister after i finally managed to peel it off [blister], one side didn't stay stuck on her skin for less than an hour and the other side gave her a water blister [device adhesion issue], narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: aa2478) from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported "y'all need to equally distribute the adhesive or something", one side didn't stay stuck on her skin for less than an hour.The patient even made sure that her lower back was clean and no clothing got stuck in the adhesive.The other side gave her a water blister after she finally managed to peel it off on an unspecified date.Action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group: site sample was not received.This investigation conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a 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 /negligible-minor.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend actions taken: a lot trend was not performed as the lot number is unknown.Severity of harm was provided as s3.Follow-up (14aug2020): new information received from the product quality complaint (pqc) group includes investigation results.Follow-up (22aug2020): new information received from a contactable consumer via pqc group includes: device lot number.Follow-up (31aug2020) follow-up attempts are completed.No further information is expected.Follow-up (18sep2020): new information received from a product quality complaint group included: severity of harm rating assessment.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Site sample was not received.This investigation conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a 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 /negligible-minor.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend actions taken: a lot trend was not performed as the lot number is unknown.
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Event Description
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Event verbatim [preferred term].The other side gave me a water blister after i finally managed to peel it off [blister], one side didn't stay stuck on her skin for less than an hour and the other side gave her a water blister [device adhesion issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: aa2478) from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported "y'all need to equally distribute the adhesive or something", one side didn't stay stuck on her skin for less than an hour.The patient even made sure that her lower back was clean and no clothing got stuck in the adhesive.The other side gave her a water blister after she finally managed to peel it off on an unspecified date.Action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group: site sample was not received.This investigation conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a 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 /negligible-minor.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend actions taken: a lot trend was not performed as the lot number is unknown.Follow-up (14aug2020): new information received from the product quality complaint (pqc) group includes investigation results.Follow-up (22aug2020): new information received from a contactable consumer via pqc group includes: device lot number.
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Manufacturer Narrative
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Site sample was not received.This investigation conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a 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 /negligible-minor.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend actions taken: a lot trend was not performed as the lot number is unknown.
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Manufacturer Narrative
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Site sample was not received.This investigation conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a 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 /negligible-minor.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend actions taken: a lot trend was not performed as the lot number is unknown.
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Event Description
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Event verbatim [preferred term] the other side gave me a water blister after i finally managed to peel it off [blister], one side didn't stay stuck on her skin for less than an hour and the other side gave her a water blister [device adhesion issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported "y'all need to equally distribute the adhesive or something", one side didn't stay stuck on her skin for less than an hour.The patient even made sure that her lower back was clean and no clothing got stuck in the adhesive.The other side gave her a water blister after she finally managed to peel it off on an unspecified date.Action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group: site sample was not received.This investigation conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a 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 /negligible-minor.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Lot trend actions taken: a lot trend was not performed as the lot number is unknown.Follow-up (14aug2020): new information received from product quality complaint group includes investigation results.
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Event Description
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Event verbatim [preferred term].The other side gave me a water blister after i finally managed to peel it off [blister], one side didn't stay stuck on her skin for less than an hour and the other side gave her a water blister [device adhesion issue], narrative: this is a spontaneous report from a contactable consumer (patient).A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number aa2378, expiration date nov2021) from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported "y'all need to equally distribute the adhesive or something", one side didn't stay stuck on her skin for less than an hour.The patient even made sure that her lower back was clean and no clothing got stuck in the adhesive.The other side gave her a water blister after she finally managed to peel it off on an unspecified date.Action taken in response to the events for thermacare heatwrap was unknown.The events outcome was unknown.According to product quality complaint group: severity of harm was provided as s3.Summary of investigation: batch aa2378 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for m&j products.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "one side didn't stay stuck on my skin for less than an hour" and "the other side gave me a water blister after i finally managed to peel it off." the cause of the consumer statement "one side didn't stay stuck on my skin for less than an hour" and "the other side gave me a water blister after i finally managed to peel it off" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body and cause a blister for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Root cause/capa: process related was no.Final confirmation status was not confirmed.The sample was received at the site on 10nov2020.Return sample evaluation: three m&j pouches (l) aa2378 n 06dec exp nov2021 23:47 pouches are sealed.No obvious defects.Three m&j wraps - wraps are inside sealed pouches.Opened one pouch to inspect the wrap; no obvious defects to wrap.Follow-up ((b)(6) 2020): new information received from the product quality complaint (pqc) group includes investigation results.Follow-up ((b)(6) 2020): new information received from a contactable consumer via pqc group includes: device lot number.Follow-up ((b)(6) 2020) follow-up attempts are completed.No further information is expected.Follow-up ((b)(6) 2020): new information received from a product quality complaint group included: severity of harm rating assessment.Follow-up attempts are completed.No further information is expected.Follow-up ((b)(6) 2020): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Summary of investigation: batch aa2378 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) requiring an evaluation for this batch.On this basis, a trend is not identified in this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for m&j products.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "one side didn't stay stuck on my skin for less than an hour" and "the other side gave me a water blister after i finally managed to peel it off." the cause of the consumer statement "one side didn't stay stuck on my skin for less than an hour" and "the other side gave me a water blister after i finally managed to peel it off" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body and cause a blister for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Root cause/capa: process related was no.Final confirmation status was not confirmed.The sample was received at the site on 10nov2020.Return sample evaluation: three m&j pouches (l) aa2378 n (b)(6) exp nov2021 23:47 pouches are sealed.No obvious defects.Three m&j wraps - wraps are inside sealed pouches.Opened one pouch to inspect the wrap; no obvious defects to wrap.
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