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Summary of investigation: this investigation was conducted for an unknown lot number of lower back/hip lbh 8 hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or 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 safety request.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 and/or 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 safety request for investigation.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the number is unknown.
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Event verbatim [preferred term] skin was getting too hot, it was not cooling off.[skin warm].Case narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6)-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number t81951, expiration date dec2020, from an unspecified for back pain.There were no medical history and no concomitant medications.The patient was calling about thermacare heatwrap back pain therapy up to 16 hr relief.The patient stated he received a notification from (delivery site name) through which purchased this product and was notified there was a possible issue with the product.There was a recall.He thought he purchased two boxes with two wraps in each.The patient confirmed he had used one box.He still had a box with to wraps/patches unopened.The box he already used he had no idea what the lot was.The patient explained he was not sure if the one that was actually used was one of the ones involved in the recall.The patient explained he used these sometime in 2018, second have of the year.He stated it was many months ago and he did not remember all these dates and details.The patient would use product for his back pain.The patient later explained he only used one of the wraps for a couple of hours and removed it because his skin was getting too hot on an unspecified date.He explained he used the other wrap for a longer period of time and the same thing happened.He further clarified and explained he used the first wrap maybe for 8-10 hours, later clarified as 6-8 hours.He was trying to get the benefit of using product.He then decided to take it off because his skin was getting too hot, it was not cooling off.The patient removed the wrap.Initially stated he believed he applied a cold wash cloth onto his skin to cool down.He later clarified it might not have been a cold wash cloth, but more so a cold pack.He stated he had cold packs that he usually applied whenever he gets muscular pain.He probably used this instead and not a cool wash cloth.Due not this happening the first time he was more aware, the second time he applied it, his skin was getting too hot again, he discontinued use.The patient stated this time was more memorable and he took it off after 2-3 hours.The patient initially mentioned this could have been due to using another heating item the first time his skin got too hot, a heading pad.Attempted to clarify statement, and caller stated, this may have been with the second occurrence.He was not sure.Second box that was unopened and not used: lot: t81951, expiration date: dec2020.There was no investigation assessment.The action taken in response to the event for thermacare heatwrap was discontinued.The event outcome was unknown.The reporter denied any seriousness criteria for the events.The reporter considered there was a reasonable possibility that skin getting too hot was related to this device.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number of lower back/hip lbh 8 hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or 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 safety request.Site 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 and/or 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 safety request for investigation.The 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.Lot trend assmt.& rationale: a lot trend was not performed as the number is unknown.Dchu conclusion: based on the complaint narrative, the patient experienced the skin becoming too hot after product use.Review of complaint description concludes there is no device malfunction.Severity of harm: s3.Follow up (31may2019): new information received from product quality complaints groups included: investigation results.Follow-up(26jun2019): follow-up attempts are completed.No further information is expected.Follow up (01aug2019): new information received from product quality complaints groups included: investigation results.Follow-up (01aug2019 and 15oct2019): this is a follow-up spontaneous report from product quality complaints group included: severity of harm s3 and dchu conclusion.Follow-up (10jul2019): this follow-up report is being submitted to upgrade this case to a serious malfunction reportable mdr.Company clinical evaluation comment: based on the information provided, the event skin warm as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the event skin warm as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
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