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For complaint sub-class: wrap/patch/pad too hot, conclusion: the root cause category is non-assignable (complaint can not be confirmed as a quality defect).Sample is not available for evaluation by the site to confirm a manufacturing quality defect.The consumer reported the heat wrap too hot.The cause of the consumers complaint is inconclusive since review of records does not provide evidence to support a defective product.The product effect may vary with each individual.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.After a review of the batch thermal records, thermal data results show all wraps met the required wrap batch average temperatures.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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for 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 wrap/patch/pad too hot for nsw 8hr products.Severity of harm was s3.For complaint sub-class: adhesion/fastening defect, conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body 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.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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adhesion/fastening defect received at the (site name) requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Severity of harm was s1.Site sample status was not received.
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Did notice that it did get awful hot [device issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number cw9500, expiration date oct2022, udi number (b)(4), from (b)(6) 2020 at 1 wrap to neck area for stiff neck.Medical history included injured her knee on the tennis court.The patient's concomitant medications were not reported.The patient said while watching tv, she was laying on a pillow and it was causing her neck to get stiff.She said it may have been 3 pillows.She used these thermacare heatwraps for neck and they did not want to stay on.She tried one and it kept falling off.She pressed down on it like it said, and held it for 30 seconds to a minute.The adhesive would not adhere to her skin.She tried two of them.She also had a problem in the past.It was a long time ago.She had injured her knee on the tennis court.That one did not stay on either, especially like when walking with it.It did not want to stay on, no matter how tight she put it.It was just like the neck wrap.She tried to press it down.She almost thought about using gorilla tape and did not, because she thought it would be toxic to her skin.At first she was reluctant to use, because it says to use caution if you are 55 and older.If so, you have more chance of blistering and redness and she did not notice any of that.She did notice that it did get awful hot.When she could not get it to stick and was laying watching tv, it did help though.At night, when she was lying on a pillow, she fell asleep watching tv in a weird position, and caused her neck to get stiff.She used it on (b)(6) 2020, tuesday night.She was doing a lot of shopping and was running errands and did not want her neck to hurt.She did not have a lot or expiration for previous thermacare product she used and did not stick.She mentioned that one side stuck more than the other.She did not provide if the product she called about before was the same product.She stated when she called before, she believes it was pfizer, she was not sure.Action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: for complaint sub-class: wrap/patch/pad too hot, conclusion: the root cause category is non-assignable (complaint can not be confirmed as a quality defect).Sample is not available for evaluation by the site to confirm a manufacturing quality defect.The consumer reported the heat wrap too hot.The cause of the consumers complaint is inconclusive since review of records does not provide evidence to support a defective product.The product effect may vary with each individual.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.After a review of the batch thermal records, thermal data results show all wraps met the required wrap batch average temperatures.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.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the (site name) requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for 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 wrap/patch/pad too hot for nsw 8hr products.Severity of harm was s3.For complaint sub-class: adhesion/fastening defect, conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body 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.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 quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adhesion/fastening defect received at the (site name) requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Severity of harm was s1.Site sample status was not received.No follow-up attempts are needed.No further information is expected.
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