|
Device Problems
Break (1069); Leak/Splash (1354)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Event Description
|
This is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), unknown device lot number and expiration from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated thermacare lower back and hip, heat wrap fell apart and the black stuff inside the wrap, came out on an unspecified date.A sample of the product was not available to be returned (she does not have the thermacare lower back).The patient stated this black stuff ended up ruining her bathroom carpets.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.No follow-up attempts needed.No further information expected.Follow-up (27nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "heat wrap fell apart and the black stuff inside the wrap, came out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "heat wrap fell apart and the black stuff inside the wrap, came out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.
|
|
Event Description
|
Event verbatim [preferred term] thermacare lower back and hip, heat wrap fell apart and the black stuff inside the wrap, came out.[device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), unknown device lot number and expiration from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated thermacare lower back and hip, heat wrap fell apart and the black stuff inside the wrap, came out on an unspecified date.A sample of the product was not available to be returned (she does not have the thermacare lower back).The patient stated this black stuff ended up ruining her bathroom carpets.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included: reasonably suggest device malfunction: yes.Severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (27nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (10nov2019): new information received from product quality complaint group included: malfunction assessment and severity of harm.Company clinical evaluation comment: the event "heat wrap fell apart and the black stuff inside the wrap, came out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "heat wrap fell apart and the black stuff inside the wrap, came out" (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.
|
|
Manufacturer Narrative
|
Reasonably suggest device malfunction: yes.Severity of harm: s3.Was capa previously identified?: no.Regulatory impact: no.Process related?: no.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Summary of investigation and conclusion: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 heat 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.Document review summary: there is no device history report (dhr) reviewed for an unknown batch number.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: date of contact: 27nov2015 through 27nov2018//manufacturing site, complaint class: product appearance /complaint sub class: cells damaged/leaking - heat cells damaged/leaking.The citi customizable search returned a total of 57 complaints for lower back/hip (lbh) 8hr products during this time period for the class/subclass.Of the 57 complaints; 9 of the 57 records were identified as having a manufacturing related root cause of the wrap having heat cells damaged/ leaking defects.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass cells damaged/leaking and heat cells damaged/leaking fo.
|
|
Event Description
|
Event verbatim [preferred term] when she got up one night she noticed the heat wrap fell apart [device use error] , thermacare lower back and hip, heat wrap fell apart and the black stuff inside the wrap, came out.[device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip), with unknown device lot number and expiration date from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient had the wrap thermacare lower back and hip in which she had issues with, when she got up one night she noticed the heat wrap fell apart and the black stuff inside the wrap, came out on an unspecified date.A sample of the product was not available to be returned (she does not have the thermacare lower back).The patient also reported that "this black stuff ended up ruining her bathroom carpets." the action taken with thermacare heatwrap and outcome of the event were unknown.Additional information received from product quality complaint (pqc) group included: reasonably suggest device malfunction: yes.Severity of harm: s3.Was capa previously identified?: no.Regulatory impact: no.Process related?: no.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Summary of investigation and conclusion: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 heat 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.Document review summary: there is no device history report (dhr) reviewed for an unknown batch number.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: date of contact: 27nov2015 through 27nov2018//manufacturing site, complaint class: product appearance /complaint sub class: cells damaged/leaking - heat cells damaged/leaking.The citi customizable search returned a total of 57 complaints for lower back/hip (lbh) 8hr products during this time period for the class/subclass.Of the 57 complaints; 9 of the 57 records were identified as having a manufacturing related root cause of the wrap having heat cells damaged/ leaking defects.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass cells damaged/leaking and heat cells damaged/leaking for lbh 8hr products.No further action is required.Follow-up (27nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (10nov2019): new information received from product quality complaint group included: malfunction assessment and severity of harm.Follow-up (11nov2019, 15nov2019): new information received from product quality complaint group included: summary of investigation and conclusion, document review summary, other investigation findings, and new event "when she got up one night she noticed the heat wrap fell apart".Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: the event "when she got up one night she noticed the heat wrap fell apart and the black stuff inside the wrap, came out" was assessed as non-serious.No other adverse event was associated with the use of the device.Device leakage is a single potential device malfunction 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.In the case narrative, there is evidence of device use error which most likely contributed to this incident.No further investigations or actions is suggested at this time., comment: the event "when she got up one night she noticed the heat wrap fell apart and the black stuff inside the wrap, came out" was assessed as non-serious.No other adverse event was associated with the use of the device.Device leakage is a single potential device malfunction 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.In the case narrative, there is evidence of device use error which most likely contributed to this incident.No further investigations or actions is suggested at this time.
|
|
Search Alerts/Recalls
|
|
|