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| Device Problem
Unintended Ejection (1234)
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| Patient Problems
Skin Discoloration (2074); Burn, Thermal (2530)
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| Event Date 11/01/2018 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] has a mark, some kind of burn on his lower back [thermal burn] , has a mark, some kind of a burn mark, for like a week no; it is a dark, dry, skin discoloration [skin discolouration] , he still has a mark on his lower back where it leaked [device leakage].Case narrative: this is a spontaneous report from a contactable consumer (patient).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare muscle & joint), 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 stated that he wore this product every so often and he never had a left over mark from it.The patient stated that he put one on last monday, (b)(6) 2018 and he had some kind of reaction.He had a mark, some kind of burn on his lower back on an unspecified date in (b)(6) 2018.He stated he did not realize there was a recall.He had a mark, some kind of a burn mark, for like a week now, on an unspecified date in (b)(6) 2018.He added that he still had a mark on his lower back where it leaked.Clarified that he said leaked, and he said he would assume leaked.He wanted to know what had leaked into his body and would like to figure out what he needs to do.Now it was a dark, dry, skin discoloration.He had thought it might have been from the sticky or whatever, but it hadn't gone away in the last 10 days, or however many days he was at now.He stated he wanted to know what his exposure is to whatever was leaking out of it.He added he obviously had it on his body for 8 hours so it was a little concerning.The action taken with thermacare heatwrap in response to the events was unknown.The outcome of the events "has a mark, some kind of burn on his lower back," was unknown.The outcomes of the other events had not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2019): follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: the events "he still had a mark on his lower back where it leaked" (device leakage), "some kind of burn" and skin discoloration were assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The events were assessed as associated with the use of the device., comment: the events "he still had a mark on his lower back where it leaked" (device leakage), "some kind of burn" and skin discoloration were assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The events were assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] has a mark, some kind of burn on his lower back/has a mark, some kind of a burn mark, for like a week no; it is a dark, dry, skin discoloration [thermal burn] , he still has a mark on his lower back where it leaked [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare muscle & joint), 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 stated that he wore this product every so often and he never had a left over mark from it.The patient stated that he put one on last monday, (b)(6) 2018 and he had some kind of reaction.He had a mark, some kind of burn on his lower back on an unspecified date in (b)(6) 2018.He stated he did not realize there was a recall.He had a mark, some kind of a burn mark, for like a week now, on an unspecified date in (b)(6) 2018.He added that he still had a mark on his lower back where it leaked.Clarified that he said leaked, and he said he would assume leaked.He wanted to know what had leaked into his body and would like to figure out what he needs to do.Now it was a dark, dry, skin discoloration.He had thought it might have been from the sticky or whatever, but it hadn't gone away in the last 10 days, or however many days he was at now.He stated he wanted to know what his exposure is to whatever was leaking out of it.He added he obviously had it on his body for 8 hours so it was a little concerning.The action taken with thermacare heatwrap in response to the events was unknown.The outcome of the event "burn" was unknown.The outcomes of the other events had not resolved.Additional information received from product quality complaint (pqc) group included: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hour.Additional information has been requested and will be provided as it becomes available.Follow-up (04apr2019): follow-up attempts are completed.No further information is expected.Follow-up (29nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (11nov2019): new information received from product quality complaints group included: impact analysis, severity rating and case upgraded to serious.Company clinical evaluation comment: based on the available information, the events thermal burn and device leakage as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.A causal relationship between the device and the events cannot be ruled out., comment: based on the available information, the events thermal burn and device leakage as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.A causal relationship between the device and the events cannot be ruled out.
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Event Description
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Event verbatim [preferred term] has a mark, some kind of burn on his lower back/has a mark, some kind of a burn mark, for like a week no; it is a dark, dry, skin discoloration [thermal burn] , he still has a mark on his lower back where it leaked [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare muscle & joint), 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 stated that he wore this product every so often and he never had a left over mark from it.The patient stated that he put one on last monday, (b)(6) 2018 and he had some kind of reaction.He had a mark, some kind of burn on his lower back on an unspecified date in (b)(6) 2018.He stated he did not realize there was a recall.He had a mark, some kind of a burn mark, for like a week now, on an unspecified date in (b)(6) 2018.He added that he still had a mark on his lower back where it leaked.Clarified that he said leaked, and he said he would assume leaked.He wanted to know what had leaked into his body and would like to figure out what he needs to do.Now it was a dark, dry, skin discoloration.He had thought it might have been from the sticky or whatever, but it hadn't gone away in the last 10 days, or however many days he was at now.He stated he wanted to know what his exposure is to whatever was leaking out of it.He added he obviously had it on his body for 8 hours so it was a little concerning.The action taken with thermacare heatwrap in response to the events was unknown.The outcome of the event "burn" was unknown.The outcomes of the other events had not resolved.Additional information received from product quality complaint (pqc) group included: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hour.Product investigation results were as follows: appearance /complaint sub class: heat cells damaged/leaking and cells damaged/leaking.The citi customizable search returned a total of 14 complaint for muscle and joint 8hr products during this time period for the class/subclass.Three of the 14 complaints were confirmed as having a manufacturing related root cause of the wrap having heat cells/damaged/ leaking and cells damaged/leaking.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.Create an mwi for purging brine.This document needs to provide instructions on how to verify air isn't within the supply lines and it should provide instruction on how to ensure the lines are secure to the connectors to prevent any air from entering the system.Also, the document should provide instructions on how long to purge based off of the downtime.This investigation was conducted for an unknown lot number muscle and joint 8hr product.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 cells damaged/leaking.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.Additional information has been requested and will be provided as it becomes available.Follow-up (04apr2019): follow-up attempts are completed.No further information is expected.Follow-up (29nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (11nov2019): new information received from product quality complaints group included: impact analysis, severity rating and case upgraded to serious.Follow-up (21nov2019): new information received from a product quality complaint group includes product investigation summary results.Company clinical evaluation comment: based on the available information, the events thermal burn and device leakage as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.A causal relationship between the device and the events cannot be ruled out.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the available information, the events thermal burn and device leakage as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Device leakage is a single potential device malfunction which has a theoretical risk to cause skin burn.A causal relationship between the device and the events cannot be ruled out.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Appearance /complaint sub class: heat cells damaged/leaking and cells damaged/leaking.The citi customizable search returned a total of 14 complaint for muscle and joint 8hr products during this time period for the class/subclass.Three of the 14 complaints were confirmed as having a manufacturing related root cause of the wrap having heat cells/damaged/ leaking and cells damaged/leaking.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.Create an mwi for purging brine.This document needs to provide instructions on how to verify air isn¿t within the supply lines and it should provide instruction on how to ensure the lines are secure to the connectors to prevent any air from entering the system.Also, the document should provide instructions on how long to purge based off of the downtime.This investigation was conducted for an unknown lot number muscle and joint 8hr product.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 cells damaged/leaking.The manufacturing operations employ quality control procedures which include in process testing, thermal te.
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Search Alerts/Recalls
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