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| Lot Number T48941 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abrasion (1689); Bruise/Contusion (1754); Contusion (1787)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] every time i use it directly on the skin i get bruised and abrasions.It damages my skin [contusion] , every time i use it directly on the skin i get bruised and abrasions.It damages my skin [skin abrasion].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), device lot number t48941, expiration date aug2020, from 2018 (probably a year ago) to 06mar2019 at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated "do you sell a product for upper back pain?" every time he used it directly on the skin he got bruised and abrasions on an unspecified date.It damaged his skin.This happened about a half dozen times.He used them over a t-shirt.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (13jun2019): follow-up attempts are completed.No further information is expected.Follow-up (06mar2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events contusion and skin abrasion 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., comment: based on the information provided, the events contusion and skin abrasion 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.
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Event Description
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Event verbatim [preferred term] every time i use it directly on the skin i get bruised and abrasions.It damages my skin [contusion] , every time i use it directly on the skin i get bruised and abrasions.It damages my skin [skin abrasion].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), device lot number t48941, expiration date 31aug2020, from 2018 (probably a year ago) at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated "do you sell a product for upper back pain?" every time he used it directly on the skin he got bruised and abrasions on an unspecified date.It damaged his skin.This happened about a half dozen times (a yea to a year an a half ago).He used them over a t-shirt.A sample was available for evaluation.The action taken in response to the events for thermacare heatwrap was permanently discontinued on 06mar2019.The outcome of the events was unknown.Additional information received from product quality complaint group: severity of harm was s3.Complaint class: external cause investigation.Complaint sub-class: adverse event safety request for investigation.Sample was available, and requested.Sterile-product: no.It reasonably suggests no device malfunction with severity of harm ranking n/a (discrepant from previous s3, queried).No capa previously identified and full investigation not required no complaint confirmed as a defect as per sop, processing consumer complaints.Investigation findings: batch t48941 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "every time i use it directly on the skin i get bruised and abrasions." the cause of the consumer receiving a bruise and abrasion is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of 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.Document review summary: batch t48941 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.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch involving wraps not heating for use.Reserve sample evaluation required and performed on 11sep2019 on an unrelated complaint, and visual reserve sample evaluation description is as follows: the visual inspection of retain samples included one carton and three pouched wraps inside.Inspection shows no obvious defects to carton or pouched wraps.No reserve sample testing required.Reserve defect not confirmed.No lot-specific nor expedite trend were identified.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the third complaint for the subclass adverse event safety request for investigation received at the albany site for this batch.The previous complaints have not been confirmed to have a manufacturing root cause related to the subclass.Per sop, complaint trending guideline, a visual evaluation was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this batch.There are no other trend identified.Site sample status: not received.Follow-up (13jun2019): follow-up attempts are completed.No further information is expected.Follow-up (06mar2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (04nov2019): new information received from a product quality complaint group included: severity ranking.Follow-up (17dec2019): new information received from a product quality complaint group included: complaint class and subclass, sample availability and status, investigation findings, conclusion, document review summary, and reserve sample evaluation.Company clinical evaluation comment: based on the information provided, the events contusion and skin abrasion as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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 events contusion and skin abrasion as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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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Severity of harm was s3.Complaint class: external cause investigation.Complaint sub-class: adverse event safety request for investigation.Sample was available, and requested.Sterile-product: no.It reasonably suggests no device malfunction with severity of harm ranking n/a (discrepant from previous s3, queried).No capa previously identified and full investigation not required no complaint confirmed as a defect as per sop, processing consumer complaints.Investigation findings: batch t48941 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "every time i use it directly on the skin i get bruised and abrasions." the cause of the consumer receiving a bruise and abrasion is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of 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.Document review summary: batch t48941 is the only batch within the scope of this investigation.Thermacare.
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Event Description
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Event verbatim [preferred term] every time i use it directly on the skin i get bruised and abrasions.It damages my skin [contusion] , every time i use it directly on the skin i get bruised and abrasions.It damages my skin [skin abrasion] ,.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), device lot number t48941, expiration date (b)(6) 2020, from 2018 (probably a year ago) to (b)(6) 2019 at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated "do you sell a product for upper back pain?" every time he used it directly on the skin he got bruised and abrasions on an unspecified date.It damaged his skin.This happened about a half dozen times (a yea to a year an a half ago).He used them over a t-shirt.A sample was available for evaluation.The action taken in response to the events for thermacare heatwrap was permanently discontinued on (b)(6) 2019.The outcome of the events was unknown.Additional information received from product quality complaint group: severity of harm was s3.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) 2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up ((b)(6) 2019): new information received from a product quality complaint group included: severity ranking.Company clinical evaluation comment: based on the information provided, the events contusion and skin abrasion as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out., comment: based on the information provided, the events contusion and skin abrasion as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.
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Manufacturer Narrative
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No capa previously identified and full investigation not required no complaint confirmed as a defect as per sop, processing consumer complaints.Investigation findings: batch t48941 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "every time i use it directly on the skin i get bruised and abrasions." the cause of the consumer receiving a bruise and abrasion is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of 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.Document review summary: batch t48941 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.
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Event Description
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Event verbatim [preferred term] every time i use it directly on the skin i get bruised and abrasions.It damages my skin [contusion] , every time i use it directly on the skin i get bruised and abrasions.It damages my skin [skin abrasion].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), device lot number t48941, expiration date 31aug2020, from 2018 (probably a year ago) at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient stated "do you sell a product for upper back pain?" every time he used it directly on the skin he got bruised and abrasions on an unspecified date.It damaged his skin.This happened about a half dozen times (a year to a year and a half ago).He used them over a t-shirt.A sample was available for evaluation.The action taken in response to the events for thermacare heatwrap was permanently discontinued on (b)(6) 2019.The outcome of the events was unknown.Additional information received from product quality complaint group: per dchu: severity of harm was s3.Complaint class: external cause investigation.Complaint sub-class: adverse event safety request for investigation.Sample was available, and requested.Sterile-product: no.Per site: no capa previously identified and full investigation not required no complaint confirmed as a defect as per sop, processing consumer complaints.Investigation findings: batch t48941 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.There was no impact on regulatory, product quality, market /clinical, and stability.It was not process related, and final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "every time i use it directly on the skin i get bruised and abrasions." the cause of the consumer receiving a bruise and abrasion is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of 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.Document review summary: batch t48941 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.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch involving wraps not heating for use.Reserve sample evaluation required and performed on 11sep2019 on an unrelated complaint, and visual reserve sample evaluation description is as follows: the visual inspection of retain samples included one carton and three pouched wraps inside.Inspection shows no obvious defects to carton or pouched wraps.No reserve sample testing required.Reserve defect not confirmed.No lot-specific nor expedite trend were identified.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the third complaint for the subclass adverse event safety request for investigation received at the site for this batch.The previous complaints have not been confirmed to have a manufacturing root cause related to the subclass.Per sop, complaint trending guideline, a visual evaluation was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this batch.There are no other trend identified.Site sample status: not received.Follow-up (13jun2019): follow-up attempts are completed.No further information is expected.Follow-up (06mar2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (04nov2019): new information received from a product quality complaint group included: severity ranking.Follow-up (17dec2019): new information received from a product quality complaint group included: complaint class and subclass, sample availability and status, investigation findings, conclusion, document review summary, and reserve sample evaluation.Follow-up (26dec2019): new information received in response to the query included: confirmation of severity of harm provided by dchu and the site.Company clinical evaluation comment: based on the information provided, the events contusion and skin abrasion as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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 events contusion and skin abrasion as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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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Search Alerts/Recalls
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