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| Lot Number CW7747 |
| Device Problems
Loss of or Failure to Bond (1068); Use of Device Problem (1670); Detachment of Device or Device Component (2907); Excessive Heating (4030)
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| Patient Problems
Pain (1994); Skin Tears (2516)
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Event Type
malfunction
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Manufacturer Narrative
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Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.Refer to the 24-month lot trend chart attachment adverse event/negligible-minor lot cw7747 15june2018 to 15june2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site.Date samples were received was 25jun2020.Three nsw8 wraps - the end tabs measured within specification, no obvious defects.
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Event Description
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She felt like it was ripping her skin with it/ very painful [pain of skin], tab on the right side of the wrap got very stuck to her skin/ was hard to take off [device adhesion issue], for tension and headaches [device use issue], they got too hot [device issue].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number cw7747, expiration date sep2022, from an unspecified date for tension and headaches.The patient's medical history and concomitant medications were not reported.The patient stated the tab on the right side of the wrap got very stuck to her skin/ was hard to take off and she felt like it was ripping her skin with it and it was very painful on an unspecified date.The patient also reported her thermacare neck wraps, two boxes, would not stick on (pending clarification) and they got too hot.She returned the wraps to us.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: summary of investigation: batch #: cw7747 brand code/sku#: f00573301502x; product count: 3 count; date of manufacture: 15oct2019 to 23oct2019.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site.Date samples were received was 25jun2020.Three nsw8 wraps - the end tabs measured within specification, no obvious defects.Severity of harm was provided as s2.Follow-up (17aug2020): new information received from the product quality complaint group included investigational results.No follow up attempts are needed.No further information is expected.Follow-up (09sep2020): new information received from the product quality complaint group included updated investigational results.No follow-up attempts are needed.No further information is expected.Follow-up (05nov2020): new information received from a contactable consumer includes new event (would not stick on and they got too hot), case upgraded to reportable malfunction.No follow-up attempts are needed.No further information is expected.
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Manufacturer Narrative
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Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.Refer to the 24-month lot trend chart attachment adverse event/negligible-minor lot cw7747 15june2018 to 15june2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site.Date samples were received was 25jun2020.Three nsw8 wraps - the end tabs measured within specification, no obvious defects.According to the product quality complaint group for sub-class: wrap/patch/pad too hot.Batch cw7747 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 wraps ¿got too hot.¿ evaluation of the consumer returned sample did not provide any additional information as to why the consumer felt the wrap was too hot.There were no obvious defects to returned wraps.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.Lot trend assmt.& 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 this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Refer to the 36-month trending chart attachment nsw 8hr wrap/patch/pad too hot (b)(6) 2017 through (b)(6) 2020.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site.Date samples were received (gmt): 25jun2020.Return sample evaluation: three nsw8 wraps - the end tabs measured within specification, no obvious defects.Three nsw8 pouches (l) cw7747 n (b)(6) 2017 exp sep2022 01:43 pouches opened by inspector.One nsw8 carton (l) cw7747 n (b)(6) 2017 exp sep2022 01:46.According to the product quality complaint group for sub-class: adhesion/fastening defect.Severity of harm was s1.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the returned sample did not provide any additional information as to why the consumer "states it was hard to take off and she felt like it was ripping her skin with it." there were no obvious defect to the returned wraps.After a review of the (name) material records for the batches of (name) used in this batch the root cause of why the wrap "was hard to take off" and "was ripping her skin with it" is inconclusive since review of records does not provide evidence to support defective product.(name) 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 12th complaint for the sub class adhesion/fastening defect received at the (site name) requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site.Date samples were received (gmt): 25jun2020.Return sample evaluation: three wrap- end tabs measured within specification.No obvious defects.Three pouch- (l) cw7747 n 17oct exp.Sep2022 01:43 pouches opened by inspector.One carton- (l) cw7747 (b)(6) exp.Sep2022 01:46 carton opened by inspector.One # carton (l) cw7747 n (b)(6) exp sep2022 04:00 carton is opened by consumer.Three # pouches (l) cw7747 n (b)(6) exp sep2022 03:57 pouches opened by consumer.Two # wraps - the end tabs measured within specification, no obvious defects.
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Event Description
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Event verbatim [preferred term], she felt like it was ripping her skin with it/ very painful [pain of skin], tab on the right side of the wrap got very stuck to her skin/ was hard to take off [device adhesion issue], for tension and headaches [device use issue], they got too hot [device issue].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number cw7747, expiration date sep2022, from an unspecified date for tension and headaches.The patient's medical history and concomitant medications were not reported.The patient stated the tab on the right side of the wrap got very stuck to her skin/ was hard to take off and she felt like it was ripping her skin with it and it was very painful on an unspecified date.The patient also reported her thermacare neck wraps, two boxes, would not stick on (as reported) and they got too hot.She returned the wraps to us.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: summary of investigation: batch #: cw7747 brand code/sku#: f00573301502x; product count: 3 count; date of manufacture: 15oct2019 to 23oct2019.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site.Date samples were received was 25jun2020.Three nsw8 wraps - the end tabs measured within specification, no obvious defects.Severity of harm was provided as s2.According to the product quality complaint group for sub-class: wrap/patch/pad too hot.Batch cw7747 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 wraps "got too hot." evaluation of the consumer returned sample did not provide any additional information as to why the consumer felt the wrap was too hot.There were no obvious defects to returned wraps.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.Lot trend assmt.& 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 this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Refer to the 36-month trending chart attachment nsw 8hr wrap/patch/pad too hot (b)(6) 2017 through (b)(6) 2020.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site.Date samples were received (gmt): 25jun2020.Return sample evaluation: three nsw8 wraps - the end tabs measured within specification, no obvious defects.Three nsw8 pouches (l) cw7747 n (b)(6) 2017 exp sep2022 01:43 pouches opened by inspector.One nsw8 carton (l) cw7747 n (b)(6) 2017 exp sep2022 01:46.According to the product quality complaint group for sub-class: adhesion/fastening defect.Severity of harm was s1.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the returned sample did not provide any additional information as to why the consumer "states it was hard to take off and she felt like it was ripping her skin with it." there were no obvious defect to the returned wraps.After a review of the (name) material records for the batches of (name) used in this batch the root cause of why the wrap "was hard to take off" and "was ripping her skin with it" is inconclusive since review of records does not provide evidence to support defective product.(name) 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 12th complaint for the sub class adhesion/fastening defect received at the (site name) requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site.Date samples were received (gmt): 25jun2020.Return sample evaluation: three wrap- end tabs measured within specification.No obvious defects.Three pouch- (l) cw7747 n 17oct exp.Sep2022 01:43 pouches opened by inspector.One carton- (l) cw7747 (b)(6) exp.Sep2022 01:46 carton opened by inspector.One # carton (l) cw7747 n (b)(6) exp sep2022 04:00 carton is opened by consumer.Three # pouches (l) cw7747 n (b)(6) exp sep2022 03:57 pouches opened by consumer.Two # wraps - the end tabs measured within specification, no obvious defects.Follow-up (17aug2020): new information received from the product quality complaint group included investigational results.No follow up attempts are needed.No further information is expected.Follow-up (09sep2020): new information received from the product quality complaint group included updated investigational results.No follow-up attempts are needed.No further information is expected.Follow-up (05nov2020): new information received from a contactable consumer includes new event (would not stick on and they got too hot), case upgraded to reportable malfunction.No follow-up attempts are needed.No further information is expected.Follow-up (18nov2020): follow up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: current location of device was updated.Follow-up (10dec2020): new information received from product complaint group includes additional investigation results.Follow up attempts are completed.No further information is expected.Follow-up (16dec2020): new information received from product complaint group includes additional investigation results.Follow up attempts are completed.No further information is expected.
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Manufacturer Narrative
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According to the product quality complaint group for subclass sub-class: adverse event/negligible-minor: summary of investigation: batch #: cw7747 brand code/sku#: f00573301502x; product count: 3 count; date of manufacture: 15oct2019 to 23oct2019.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site on 25jun2020.Return sample evaluation: three nsw8 wraps - the end tabs measured within specification, no obvious defects.Three nsw8 pouches: (l) cw7747 n (b)(6) , exp 2022-09 01:43.Pouches opened by inspector.One nsw8 carton, (l) cw7747 (b)(6) , exp 2022-09 01:46.Additional returned sample evaluation:one nsw8 carton, (l) cw7747 n (b)(6) , exp 2022-09 04:00, carton is opened by consumer.Three nsw8 pouches, (l) cw7747 n (b)(6) , exp 2022-09 03:57, pouches opened by consumer.Two nsw8 wraps - the end tabs measured within specification, no obvious defects.Severity of harm was provided as s2.According to the product quality complaint group for sub-class: wrap/patch/pad too hot.Batch cw7747 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 wraps "got too hot." evaluation of the consumer returned sample did not provide any additional information as to why the consumer felt the wrap was too hot.There were no obvious defects to returned wraps.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.Lot trend assmt.& 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 this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Refer to the 36-month trending chart attachment nsw 8hr wrap/patch/pad too hot (b)(6) 2017 through (b)(6) 2020.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site on 25jun2020.Return sample evaluation: three nsw8 wraps - the end tabs measured within specification, no obvious defects.Three nsw8 pouches (l) cw7747 n (b)(6) 2017 exp sep2022 01:43 pouches opened by inspector.One nsw8 carton (l) cw7747 n (b)(6) 2017 exp sep2022 01:46.One nsw8 carton (l) cw7747 n (b)(6) , exp 2022-09 04:00, carton is opened by consumer.Three nsw8 pouches, (l) cw7747 n (b)(6) , exp 2022-09 03:57, pouches opened by consumer.Two nsw8 wraps - the end tabs measured within specification, no obvious defects.According to the product quality complaint group for sub-class: adhesion/fastening defect.Severity of harm was s1.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the returned sample did not provide any additional information as to why the consumer "states it was hard to take off and she felt like it was ripping her skin with it." there were no obvious defect to the returned wraps.After a review of the (name) material records for the batches of (name) used in this batch the root cause of why the wrap "was hard to take off" and "was ripping her skin with it" is inconclusive since review of records does not provide evidence to support defective product.(name) 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 12th complaint for the sub class adhesion/fastening defect received at the (site name) requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site on 25jun2020.Return sample evaluation: three wrap- end tabs measured within specification.No obvious defects.Three pouch- (l) cw7747 n (b)(6) exp.Sep2022 01:43 pouches opened by inspector.One carton- (l) cw7747 (b)(6) exp.Sep2022 01:46 carton opened by inspector.One # carton (l) cw7747 n (b)(6) exp sep2022 04:00 carton is opened by consumer.Three # pouches (l) cw7747 n (b)(6) exp sep2022 03:57 pouches opened by consumer.Two # wraps - the end tabs measured within specification, no obvious defects.
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Event Description
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Event verbatim [preferred term] she felt like it was ripping her skin with it/ very painful [pain of skin], tab on the right side of the wrap got very stuck to her skin/ was hard to take off [device adhesion issue], for tension and headaches [device use issue], they got too hot [device issue], narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number cw7747, expiration date sep2022, from an unspecified date for tension and headaches.The patient's medical history and concomitant medications were not reported.The patient stated the tab on the right side of the wrap got very stuck to her skin/ was hard to take off and she felt like it was ripping her skin with it and it was very painful on an unspecified date.The patient also reported her thermacare neck wraps, two boxes, would not stick on (as reported) and they got too hot.She returned the wraps to us.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group for subclass sub-class: adverse event/negligible-minor: summary of investigation: batch #: cw7747 brand code/sku#: f00573301502x; product count: 3 count; date of manufacture: 15oct2019 to 23oct2019.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site on 25jun2020.Return sample evaluation: three nsw8 wraps - the end tabs measured within specification, no obvious defects.Three nsw8 pouches: (l) cw7747 n (b)(6) , exp 2022-09 01:43.Pouches opened by inspector.One nsw8 carton, (l) cw7747 (b)(6) , exp 2022-09 01:46.Additional returned sample evaluation:one nsw8 carton, (l) cw7747 n (b)(6) , exp 2022-09 04:00, carton is opened by consumer.Three nsw8 pouches, (l) cw7747 n (b)(6) , exp 2022-09 03:57, pouches opened by consumer.Two nsw8 wraps - the end tabs measured within specification, no obvious defects.Severity of harm was provided as s2.According to the product quality complaint group for sub-class: wrap/patch/pad too hot.Batch cw7747 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 wraps "got too hot." evaluation of the consumer returned sample did not provide any additional information as to why the consumer felt the wrap was too hot.There were no obvious defects to returned wraps.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.Lot trend assmt.& 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 this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Refer to the 36-month trending chart attachment nsw 8hr wrap/patch/pad too hot (b)(6) 2017 through (b)(6) 2020.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site on 25jun2020.Return sample evaluation: three nsw8 wraps - the end tabs measured within specification, no obvious defects.Three nsw8 pouches (l) cw7747 n (b)(6) 2017 exp sep2022 01:43 pouches opened by inspector.One nsw8 carton (l) cw7747 n (b)(6) 2017 exp sep2022 01:46.One nsw8 carton (l) cw7747 n (b)(6) , exp 2022-09 04:00, carton is opened by consumer.Three nsw8 pouches, (l) cw7747 n (b)(6) , exp 2022-09 03:57, pouches opened by consumer.Two nsw8 wraps - the end tabs measured within specification, no obvious defects.According to the product quality complaint group for sub-class: adhesion/fastening defect.Severity of harm was s1.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the returned sample did not provide any additional information as to why the consumer "states it was hard to take off and she felt like it was ripping her skin with it." there were no obvious defect to the returned wraps.After a review of the (name) material records for the batches of (name) used in this batch the root cause of why the wrap "was hard to take off" and "was ripping her skin with it" is inconclusive since review of records does not provide evidence to support defective product.(name) 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 12th complaint for the sub class adhesion/fastening defect received at the (site name) requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site on 25jun2020.Return sample evaluation: three wrap- end tabs measured within specification.No obvious defects.Three pouch- (l) cw7747 n (b)(6) exp.Sep2022 01:43 pouches opened by inspector.One carton- (l) cw7747 (b)(6) exp.Sep2022 01:46 carton opened by inspector.One # carton (l) cw7747 n (b)(6) exp sep2022 04:00 carton is opened by consumer.Three # pouches (l) cw7747 n (b)(6) exp sep2022 03:57 pouches opened by consumer.Two # wraps - the end tabs measured within specification, no obvious defects.Follow-up (17aug2020): new information received from the product quality complaint group included investigational results.No follow up attempts are needed.No further information is expected.Follow-up (09sep2020): new information received from the product quality complaint group included updated investigational results.No follow-up attempts are needed.No further information is expected.Follow-up (05nov2020): new information received from a contactable consumer includes new event (would not stick on and they got too hot), case upgraded to reportable malfunction.No follow-up attempts are needed.No further information is expected.Follow-up (18nov2020): follow up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: current location of device was updated.Follow-up (10dec2020): new information received from product complaint group includes additional investigation results.Follow up attempts are completed.No further information is expected.Follow-up (16dec2020): new information received from product complaint group includes additional investigation results.Follow up attempts are completed.No further information is expected.Follow-up (16dec2020 and 16dec2020): new information received from product complaint group includes additional investigation results about return sample evaluation for complaint sub-class: adverse event/negligible-minor and wrap/patch/ pad too hot.Follow up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.Refer to the 24-month lot trend chart attachment adverse event/negligible-minor lot cw7747 15june2018 to 15june2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site.Date samples were received was 25jun2020.Three nsw8 wraps - the end tabs measured within specification, no obvious defects.According to the product quality complaint group for sub-class: wrap/patch/pad too hot.Batch cw7747 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 wraps ¿got too hot.¿ evaluation of the consumer returned sample did not provide any additional information as to why the consumer felt the wrap was too hot.There were no obvious defects to returned wraps.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.Lot trend assmt.& 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 this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Refer to the 36-month trending chart attachment nsw 8hr wrap/patch/pad too hot (b)(6) 2017 through (b)(6) 2020.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site.Date samples were received (gmt): 25jun2020.Return sample evaluation: three nsw8 wraps - the end tabs measured within specification, no obvious defects.Three nsw8 pouches (l) cw7747 n (b)(6) t2017 exp sep2022 01:43 pouches opened by inspector.One nsw8 carton (l) cw7747 n (b)(6) 2017 exp sep2022 01:46.
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Event Description
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Event verbatim [preferred term], she felt like it was ripping her skin with it/ very painful [pain of skin], tab on the right side of the wrap got very stuck to her skin/ was hard to take off [device adhesion issue], for tension and headaches [device use issue], they got too hot [device issue].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number cw7747, expiration date sep2022, from an unspecified date for tension and headaches.The patient's medical history and concomitant medications were not reported.The patient stated the tab on the right side of the wrap got very stuck to her skin/ was hard to take off and she felt like it was ripping her skin with it and it was very painful on an unspecified date.The patient also reported her thermacare neck wraps, two boxes, would not stick on (as reported) and they got too hot.She returned the wraps to us.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: summary of investigation: batch #: cw7747 brand code/sku#: f00573301502x; product count: 3 count; date of manufacture: 15oct2019 to 23oct2019.Batch cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site.Date samples were received was 25jun2020.Three nsw8 wraps - the end tabs measured within specification, no obvious defects.Severity of harm was provided as s2.According to the product quality complaint group for sub-class: wrap/patch/pad too hot.Batch cw7747 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.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 wraps "got too hot." evaluation of the consumer returned sample did not provide any additional information as to why the consumer felt the wrap was too hot.There were no obvious defects to returned wraps.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.Lot trend assmt.& 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 this basis, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, a trend is not identified for the subclass of wrap/patch/pad too hot.Refer to the 36-month trending chart attachment nsw 8hr wrap/patch/pad too hot (b)(6) 2017 through (b)(6) 2020.Process related was no.Final confirmation status was not confirmed.Site sample status: received at the site.Date samples were received (gmt): 25jun2020.Return sample evaluation: three nsw8 wraps - the end tabs measured within specification, no obvious defects.Three nsw8 pouches (l) cw7747 n (b)(6) 2017 exp sep2022 01:43 pouches opened by inspector.One nsw8 carton (l) cw7747 n (b)(6) 2017 exp sep2022 01:46.Follow-up (17aug2020): new information received from the product quality complaint group included investigational results.No follow up attempts are needed.No further information is expected.Follow-up (09sep2020): new information received from the product quality complaint group included updated investigational results.No follow-up attempts are needed.No further information is expected.Follow-up (05nov2020): new information received from a contactable consumer includes new event (would not stick on and they got too hot), case upgraded to reportable malfunction.No follow-up attempts are needed.No further information is expected.Follow-up (18nov2020): follow up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: current location of device was updated.Follow-up (10dec2020): new information received from product complaint group includes investigation results.Follow up attempts are completed.No further information is expected.
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Event Description
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She felt like it was ripping her skin with it/ very painful [pain of skin], tab on the right side of the wrap got very stuck to her skin/ was hard to take off [device adhesion issue], for tension and headaches [device use issue], they got too hot [device issue].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number: cw7747, expiration date: sep2022, from an unspecified date for tension and headaches.The patient's medical history and concomitant medications were not reported.The patient stated the tab on the right side of the wrap got very stuck to her skin/ was hard to take off and she felt like it was ripping her skin with it and it was very painful on an unspecified date.The patient also reported her thermacare neck wraps, two boxes, would not stick on (pending clarification) and they got too hot.She returned the wraps to us.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.According to the product quality complaint group: summary of investigation: batch#: cw7747 brand code / sku#: f00573301502x; product count: 3 count; date of manufacture: 15oct2019 to 23oct2019.Batch: cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard / painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard / painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site.Date samples were received was on (b)(6) 2020.Three nsw8 wraps - the end tabs measured within specification, no obvious defects.Severity of harm was provided as s2.Follow-up (17aug2020): new information received from the product quality complaint group included investigational results.No follow up attempts are needed.No further information is expected.Follow-up (09sep2020): new information received from the product quality complaint group included updated investigational results.No follow-up attempts are needed.No further information is expected.Follow-up (05nov2020): new information received from a contactable consumer includes new event (would not stick on and they got too hot), case upgraded to reportable malfunction.No follow-up attempts are needed.No further information is expected.Follow-up (18nov2020): follow up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: current location of device was updated.
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Manufacturer Narrative
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Batch: cw7747 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.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).The consumer stated, "the right side of the wrap got very stuck to her skin and it was hard/painful to take off".The cause of the consumers complaints is inconclusive since review of the records does not provide evidence to support a defective product.The evaluation of the returned sample did not provide any additional information of why the consumer stated "the right side of the wrap got very stuck to her skin and it was hard / painful to take off".The skin contact adhesive (sca) laminate is manufactured (at supplier) by gluing several non-woven materials together, including applying the tape that attaches the wrap to the body.After a review of the skin contact adhesive laminate (sca) material records, for the batch of sca used, 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.Lot trend assmt.& 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 albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend per sop-# complaint trending guideline, effective 24feb2020.Refer to the 24-month lot trend chart attachment adverse event / negligible-minor lot: cw7747 15june2018 to 15june2020.On this basis, a trend is not identified in this batch.Site sample status was received at the site.Date samples were received was on (b)(6) 2020.Three nsw8 wraps - the end tabs measured within specification, no obvious defects.
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Search Alerts/Recalls
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