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Conclusion: the root cause category is non assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No 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.No trends were identified for the batch.The returned sample has not been received at the site for evaluation.This batch was involved in investigation (b)(4); opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by area quality review team (aqrt) on 11apr2019.The outcome of aqrt was to recall the batches with a high cell temperature.The final scope included the following lower back and hip batches: s00639, s23902, s97473 and w37940.Document review summary: batch s97473 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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.Thermal data for the batch shows all wraps.
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If her husband was burned from a tc heatwrap/ thinks he was but didn't know [thermal burn], thinks he said it was too hot and skin itched after [pruritus], thinks he said it was too hot and skin itched after [device issue].Case narrative: this is a spontaneous report from a contactable consumer reporting for her husband.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s97473, expiry date: 31mar2020, from an unspecified date when needed for lower back pain.When the patient did something to throw out his back he wears these heat wraps for a few days.Upc number: 305733010037.Medical history was none.There were no concomitant medications.The consumer was calling about thermacare back pain therapy heat wraps, and said that she thought she had some that were recalled.She was told by her pharmacist to send them back or throw them away.The reporter states that they had one carton left, and she didn't remember if she bought two or not, though she could have.If there was another box, it was her husband who had used it.Her husband used the heat wraps for lower back pain and she thought he said it was too hot but she didn't know.She wasn't sure if he used both, but she thought he said it was too hot and his skin itched after.She didn't know if he kept it on the whole time.Reporter was later asked if her husband was burned from a tc heatwrap, she thinks he was but didn't know.She can't read the exp date because it was too small to read.She did wear glasses.Packaging was sealed and intact.Device was available for evaluation.The action taken in response to the events for thermacare heatwrap and the outcome of the events were unknown.According to product quality complaint group: conclusion: the root cause category is non assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No 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.No trends were identified for the batch.The returned sample has not been received at the site for evaluation.This batch was involved in investigation (b)(4); opened after an fda inspection to address not performing isolation after a cell with a high temperature was found during in process testing.The main root cause of the event is related to misunderstanding the corrective action procedure (cap) for investigating, retesting and isolating product with a high cell temperature.The root cause was identified as method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by area quality review team (aqrt) on 11apr2019.The outcome of aqrt was to recall the batches with a high cell temperature.The final scope included the following lower back and hip batches: s00639, s23902, s97473 and w37940.Document review summary: batch s97473 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures per (b)(4), effective: 28nov2016.There were no wrap attribute or variable defects recorded for the batch that would affect wrap temperature.On run day two laboratory investigation report (b)(4) was completed for one hot cell, an individual cell with the upper temperature of 44.7°c, above 44.0° celsius (per (b)(4), effective 28nov2016).The temperature limit for individual cells is 35.8°c to 44.0°c.Each wrap is composed of 16 cells.There were no other reports of hot cells within that wrap or within the batch.The investigation did not identify a laboratory related issue to explain the out of limits result.The lab tested 10 additional wraps and the results for individual cells passed with results of 37.1°c to 41.6°c within the limits.Event report (b)(4) was completed by manufacturing to determine the root cause.The root cause for this event is classified under equipment, mechanical failure.Production operators found brine pump a14 dosing too low.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.The production operators adjusted the pump output and resumed production.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstand the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019 and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.This batch has been reviewed from a manufacturing perspective.All site investigations associated with this batch were closed prior to releasing the batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the eighth complaint for the sub class wrap/patch/pad too hot received at the site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.Per (b)(4), complaint trending guideline, effective 05feb2019, a trend analysis using visual examination of trending graph was conducted to identify a potential trend for the subclass: an evaluation was made by searching for possible trends for this lot and subclass requiring investigation by the site.The following complaint intake, triage, and investigation customizable (citi) search was performed: scope: date contacted: 15aug2016 through 15aug2019/manufacturing site: pfizer (b)(4)/complaint class: product use attributes complaint sub class: wrap/patch/pad too hot the citi customizable search returned a total of 8 complaints for lot s97473 lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of wrap/patch/pad too hot.A trend was not identified.On the basis of this evaluation, a trend does not exist for this batch.Refer to wrap/patch/pad too hot s97473 trending graph.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation customizable (citi) search was performed.Scope: site notification date: 15aug2017 through 15aug2019/manufacturing site: pfizer (b)(4)/complaint class: product use attributes complaint sub class: wrap/patch/pad too hot the citi customizable search returned a total of 82 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of wrap/patch/pad too hot.Based on this citi search, there is a trend emerging in may for the subclass of too hot for lbh products, see attached trending graph lbh wrap patch pad too hot 15aug2017 to 15aug2019.Exped trend actions taken: there was an increase in complaints received in may2019 for wrap/patch/pad too hot due to the recall of apr2019 for lbh batches s97473, s00639, s23902, w37940.Investigation (b)(4) was completed for the trend of too hot for lbh product.There was no device malfunction identified for batches w59249, ad3849, w91244.Severity of harm: s3.Addition information was provided by product quality complaints for complaint sub-class: non-defect - label text too small/hard to read on 31jul2019: severity of harm: s1.Final confirmation status: not confirmed thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains the (site name) site is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing iines; the b ine produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaints where there is no quality defect.A non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to a non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.Follow-up (21jul2019): new information received from product quality complaint includes: expiry date of the suspect product.Follow-up (30aug2019 and 26sep2019): new information received from product quality complaint includes: severity of harm and investigation results.Follow-up (16oct2019): follow-up attempts are completed.No further information is expected.Follow-up (31jul2019 and 30aug2019): new information received from a product quality complaint group includes: additional event (if her husband was burned from a tc heatwrap/ thinks he was but didn't know) and investigation information for non-defect subclass.Follow-up dated 30aug2019 upgrades the case to a serious, reportable malfunction mdr.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of "burn" " skin itched " and "too hot" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Severity of harm: s3.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events of "burn" "skin itched" and "too hot" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Severity of harm: s3.No remedial action/corrective action/field safety corrective action is suggested at this time.
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