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| Lot Number T81953 |
| Device Problems
Leak/Splash (1354); Moisture Damage (1405)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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The last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out [device leakage].Case narrative: this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) sm/med, device lot number t81953, expiration date nov2020, from an unspecified date to an unspecified date for back pain.The patient medical history and concomitant medications were not reported.The patient experienced the last 3 he opened had moisture inside and he never seen it before.When he tipped the package over upside down the water just drips out.On an unspecified date.The consumer thinks it is water it does not have a smell.There are no chemicals that they are aware of.It was 4 in a pack.The consumer did not keep the 1st two wraps, he does third one and the 4th one that is not opened.The consumer inquired if it is okay to be used.The action taken with thermacare heatwrap and the outcome of the event was not reported.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.Comment: based on available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out/thermacare heatwraps back pain therapy has moisture inside package [device leakage].Case narrative:this is a spontaneous report from a contactable consumer reporting for his wife.A 55-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) sm/med, device lot number t81953, expiration date nov2020, from an unspecified date about a year ago, at 1 to lower back as needed for back pain/ back problems and herniated disc.There was no medical history or concomitant medications.The patient experienced the last 3 she opened had moisture inside and she had never seen it before.The event occurred on (b)(6) 2019.There are no chemicals that they are aware of and the packages are sealed.The moisture was being on the wraps themselves.They are wondering if it was 'ok to use,' or if this was normal.When the patient tipped the package over upside down the water just dripped out.The consumer thought it was water, it did not have a smell.It was 4 in a pack.The consumer did not keep the 1st two wraps, did not have the third one, and the 4th one that was not opened.It was also reported that one of the thermacare products did not heat up.They were all in the same package.It happened about 4 times.The action taken with thermacare heatwrap and the outcome of the event was not reported.A sample of the product was available to be returned.The packaging was sealed and intact.Additional information has been requested and will be provided as it becomes available.Follow-up (19dec2019): new information from the same contactable consumer includes: patient information (updated to a 55-year-old female patient; height and weight), medical history (none), product information (indication, frequency, and complaint "did not heat up"), concomitant medications (none), and event information (onset date, event details).Company clinical evaluation comment based on available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device., comment: based on available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Sterile product: no.Class/subclass: product appearance/ wet/damp/too soft sticky/melted/leaking/stuck together/stuck to packaging, and external cause investigation| adverse event/ negligible-minor.Reasonably suggests device malfunction with severity of harm ranking s3.No capa previously identified and no full investigation required.Per bpm: when reporter states the heat wrap is wet when the pouch is first opened, classify as class product appearance = wet/damp/too soft / sticky / melted / leaking / stuck together / stuck to packaging.Reason for heat wrap being wet: if a pouch is weak enough to allow air into the pouch, the wrap will sweat and the moisture will build up in the pouch, thus the wrap will feel wet when opened.This holds true also if there is a hole in the pouch.Due to cause/effect only processing for wet.Qa review & rationale, summary of investigation, and conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced device leakage with product use although the seal was intact.No serious burn injury was reported.There was no impact on regulatory, product quality, market /clinical, and stability.Process related: n/a, and final confirmation status was not confirmed.Reserve sample evaluation not required.No lot-specific trend and expedite trend were identified.Site sample status: requested, and not received.
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Event Description
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Event verbatim [preferred term] the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out/thermacare heatwraps back pain therapy has moisture inside package [device leakage].Case narrative: this is a spontaneous report from a contactable consumer reporting for his wife.A 55-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) sm/med, device lot number t81953, expiration date nov2020, from an unspecified date "about a year ago, at 1 to lower back as needed for back pain/ back problems and herniated disc".There was no medical history or concomitant medications.It was reported "the last 3 she opened had moisture inside and she had never seen it before on (b)(6) 2019." there are no chemicals that they are aware of and the packages are sealed.The moisture was being on the wraps themselves.They are wondering if it was 'ok to use,' or if this was normal.When the patient tipped the package over upside down the water just dripped out.The consumer thought it was water, it did not have a smell.It was 4 in a pack.The consumer did not keep the 1st two wraps, did not have the third one, and the 4th one that was not opened.It was also reported that all of the products were ok and heated up, one of the thermacare products did not heat up.They were all in the same package.It happened about 4 times.Also reported "this is a great product, it really helps a lot mentally." a sample of the product was available to be returned.The packaging was sealed and intact.The action taken with thermacare heatwrap and the outcome of the event was not reported.Product quality complaint group provided following information: sterile product: no.Class/subclass: product appearance/ wet/damp/too soft sticky/melted/leaking/stuck together/stuck to packaging, and external cause investigation| adverse event/ negligible-minor.Reasonably suggests device malfunction with severity of harm ranking s3.No capa previously identified and no full investigation required.Per bpm: when reporter states the heat wrap is wet when the pouch is first opened, classify as class product appearance = wet/damp/too soft / sticky / melted / leaking / stuck together / stuck to packaging.Reason for heat wrap being wet: if a pouch is weak enough to allow air into the pouch, the wrap will sweat and the moisture will build up in the pouch, thus the wrap will feel wet when opened.This holds true also if there is a hole in the pouch.Due to cause/effect only processing for wet.Qa review & rationale, summary of investigation, and conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced device leakage with product use although the seal was intact.No serious burn injury was reported.There was no impact on regulatory, product quality, market /clinical, and stability.Process related: n/a, and final confirmation status was not confirmed.Reserve sample evaluation not required.No lot-specific trend and expedite trend were identified.Site sample status: requested, and not received.Follow-up (19dec2019): new information from the same contactable consumer includes: patient information (updated to a 55-year-old female patient; height and weight), medical history (none), product information (indication, frequency, and complaint "did not heat up"), concomitant medications (none), and event information (onset date, event details).Follow-up(27dec2019): new information received from a product quality complaint group included: new event "it really helps a lot mentally", investigation class/subclass, sample status, and investigation results with severity.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.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 available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.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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Event Description
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Event verbatim [preferred term] the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out/thermacare heatwraps back pain therapy has moisture inside package [device leakage].Case narrative:this is a spontaneous report from a contactable consumer reporting for his wife.A 55-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) sm/med, device lot number t81953, expiration date nov2020, from an unspecified date "about a year ago, at 1 to lower back as needed for back pain/ back problems and herniated disc".There was no medical history or concomitant medications.It was reported "the last 3 she opened had moisture inside and she had never seen it before on (b)(6) 2019." there are no chemicals that they are aware of and the packages are sealed.The moisture was being on the wraps themselves.They are wondering if it was 'ok to use,' or if this was normal.When the patient tipped the package over upside down the water just dripped out.The consumer thought it was water, it did not have a smell.It was 4 in a pack.The consumer did not keep the 1st two wraps, did not have the third one, and the 4th one that was not opened.It was also reported that all of the products were ok and heated up, one of the thermacare products did not heat up.They were all in the same package.It happened about 4 times.Also reported "this is a great product, it really helps a lot mentally." a sample of the product was available to be returned.The packaging was sealed and intact.The action taken with thermacare heatwrap and the outcome of the event was not reported.Product quality complaint group provided following information: reasonably suggests device malfunction with severity of harm ranking s3 for sub-class: adverse event/serious/unknown.Conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced device leakage with product use although the seal was intact.No serious burn injury was reported.Review of complaint description concludes there is a device malfunction.The sample had not been received by the site.Follow-up (19dec2019): new information from the same contactable consumer includes: patient information (updated to a 55-year-old female patient; height and weight), medical history (none), product information (indication, frequency, and complaint "did not heat up"), concomitant medications (none), and event information (onset date, event details).Follow-up(27dec2019): new information received from a product quality complaint group included: new event "it really helps a lot mentally", investigation class/subclass, sample status, and investigation results with severity.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: narrative updated; qc result, additional manufacturer narrative and evaluation codes removed; case changed to a follow-up reportable mdr.Company clinical evaluation comment: based on available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device., comment: based on available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out/thermacare heatwraps back pain therapy has moisture inside package [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for his wife.A 55-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) sm/med, device lot number t81953, expiration date nov2020, from an unspecified date "about a year ago, at 1 to lower back as needed for back pain/ back problems and herniated disc".There was no medical history or concomitant medications.It was reported "the last 3 she opened had moisture inside and she had never seen it before on (b)(6) 2019." there are no chemicals that they are aware of and the packages are sealed.The moisture was being on the wraps themselves.They are wondering if it was 'ok to use,' or if this was normal.When the patient tipped the package over upside down the water just dripped out.The consumer thought it was water, it did not have a smell.It was 4 in a pack.The consumer did not keep the 1st two wraps, did not have the third one, and the 4th one that was not opened.It was also reported that all of the products were ok and heated up, one of the thermacare products did not heat up.They were all in the same package.It happened about 4 times.Also reported "this is a great product, it really helps a lot mentally." a sample of the product was available to be returned.The packaging was sealed and intact.The action taken with thermacare heatwrap and the outcome of the event was not reported.Product quality complaint group provided following information: reasonably suggests device malfunction with severity of harm ranking s3 for sub-class: adverse event/serious/unknown.Conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced device leakage with product use although the seal was intact.No serious burn injury was reported.Review of complaint description concludes there is a device malfunction.The sample had not been received by the site.Additional information received form the product quality complaint group: summary investigation: batch t81953 is the only batch within the scope of this investigation.Theremacare 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).Sample is not available for evaluation by the site; complaint cannot be confirmed.The cause of wet/damp/too soft/sticky/melted/leaking/stuck together/stuck to packaging is inconclusive due to the review of the records.Records does not provide evidence to support defective product.In general-as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A small pouch leak can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of the 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-specific trend an evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp/too soft/sticky/melted/leaking/stuck together/stuck to packaging received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Follow-up (19dec2019): new information from the same contactable consumer includes: patient information (updated to a 55-year-old female patient; height and weight), medical history (none), product information (indication, frequency, and complaint "did not heat up"), concomitant medications (none), and event information (onset date, event details).Follow-up(27dec2019): new information received from a product quality complaint group included: new event "it really helps a lot mentally", investigation class/subclass, sample status, and investigation results with severity.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: narrative updated; qc result, additional manufacturer narrative and evaluation codes removed; case changed to a follow-up reportable mdr.Follow-up (17feb2020): new information from the product quality complaint group included: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on available information, the patient reported "the last 3 he opened had moisture inside/when the tip the package over upside down the water just drips out" (device leakage), which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.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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Manufacturer Narrative
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The root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.The cause of wet/damp/too soft/sticky/melted/leaking/stuck together/stuck to packaging is inconclusive due to the review of the records.Records does not provide evidence to support defective product.In general-as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A small pouch leak can cause the wrap to prematurely heat up inside the wrapper, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of the 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.
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Search Alerts/Recalls
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