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| Lot Number CM3251 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
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| Patient Problems
Pain (1994); Burn, Thermal (2530)
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Event Type
Injury
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Event Description
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Burning/ burn blister/uncomfortable pain [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer reporting for self.This consumer of an unspecified age and gender started to use thermacare heatwrap (thermacare menstrual) (device lot number and expiration date not provided) from an unspecified date for cramps.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer reported that this particular product burning him/her.Consumer reported the wrap was not too hot as consumer wore it but closer to the end of the 8 hours max, consumer started to have an uncomfortable pain.Once wrap was removed, consumer noticed a burn blister from where the patch was positioned.Consumer reported to have used this product before and this had never happened, so consumer was quite upset.The pain from the burn was worse than the actual cramps that consumer was experiencing.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "burn blister" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.Comment: based on the information provided, the event of "burn blister" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.
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Event Description
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Event verbatim [preferred term] burning/ burn blister/uncomfortable pain [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer reporting for self.This consumer of an unspecified age and gender started to use thermacare heatwrap (thermacare menstrual) (device lot number and expiration date not provided) from an unspecified date for cramps.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer reported that this particular product burning him/her.Consumer reported the wrap was not too hot as consumer wore it but closer to the end of the 8 hours max, consumer started to have an uncomfortable pain.Once wrap was removed, consumer noticed a burn blister from where the patch was positioned.Consumer reported to have used this product before and this had never happened, so consumer was quite upset.The pain from the burn was worse than the actual cramps that consumer was experiencing.Upon follow-up, the consumer reported having sent back the "package" asked for.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Additional information has been requested and will be provided as it becomes available.Follow-up (04mar2020): new information from a contactable consumer includes: patient sent back the "package;" reporting criteria was updated.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of "burn blister" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event cannot be ruled out.
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Manufacturer Narrative
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Summary of investigation: batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister".The cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.The severity of harm is s3.Reasonably suggest device malfunction: yes.
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Event Description
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Event verbatim [preferred term]: burning/ burn blister/uncomfortable pain [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer reporting for self.This consumer of an unspecified age and gender started to use thermacare heatwrap (thermacare menstrual) (device lot number cm3251, expiration date aug2022) from an unspecified date for cramps.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer reported that this particular product burning him/her.Consumer reported the wrap was not too hot as consumer wore it but closer to the end of the 8 hours max, consumer started to have an uncomfortable pain.Once wrap was removed, consumer noticed a burn blister from where the patch was positioned.Consumer reported to have used this product before and this had never happened, so consumer was quite upset.The pain from the burn was worse than the actual cramps that consumer was experiencing.Upon follow-up, the consumer reported having sent back the "package" asked for.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Additional information received from quality complaint group: summary of investigation: batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister".The cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale:an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.The severity of harm is s3.Reasonably suggest device malfuncion: yes.Follow-up attempts are completed.No further information is expected.Follow-up (04mar2020): new information from a contactable consumer includes: patient sent back the "package;" reporting criteria was updated.Follow-up (10mar2020): new information received from a product quality complaint group includes: thermacare lot number and expiration date, investigation results., comment: based on the information provided, the event of "burn blister" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and event 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.There was no trend identified.No further investigations or actions is suggested at this time.
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Manufacturer Narrative
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Summary of investigation: batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister".The cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale:an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.The severity of harm is s3.Reasonably suggest device malfunction: yes.Batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).The return sample evaluation does not show what could have caused a burn or a blister.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister." the cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.Expedite trend assessment rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse.Site sample status: received at the site.
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Event Description
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Event verbatim [preferred term].Burning/ burn blister/uncomfortable pain [burns second degree].Narrative: this is a spontaneous report from a contactable consumer reporting for self.This consumer of an unspecified age and gender started to use thermacare heatwrap (thermacare menstrual) (device lot number cm3251, expiration date aug2022) from an unspecified date for cramps.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer reported that this particular product burning him/her.Consumer reported the wrap was not too hot as consumer wore it but closer to the end of the 8 hours max, consumer started to have an uncomfortable pain.Once wrap was removed, consumer noticed a burn blister from where the patch was positioned.Consumer reported to have used this product before and this had never happened, so consumer was quite upset.The pain from the burn was worse than the actual cramps that consumer was experiencing.Upon follow-up, the consumer reported having sent back the "package" asked for.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Additional information received from quality complaint group: summary of investigation: batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister".The cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale:an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.The severity of harm is s3.According to product complaint group on (b)(6) 2020, batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).The return sample evaluation does not show what could have caused a burn or a blister.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister." the cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.Expedite trend assessment rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse.Site sample status: received at the site.Follow-up attempts are completed.No further information is expected.Follow-up (04mar2020): new information from a contactable consumer includes: patient sent back the "package;" reporting criteria was updated.Follow-up (10mar2020): new information received from a product quality complaint group includes: thermacare lot number and expiration date, investigation results.Follow-up (27aug2020): new information received from a product complaint group included: investigation result.No follow-up attempts are needed.No further information is expected.
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Event Description
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Event verbatim [preferred term] burning/ burn blister/uncomfortable pain [burns second degree], , narrative: this is a spontaneous report from a contactable consumer reporting for self.This consumer of an unspecified age and gender started to use thermacare heatwrap (thermacare menstrual) (device lot number cm3251, expiration date aug2022) from an unspecified date for cramps.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.Consumer reported that this particular product burning him/her.Consumer reported the wrap was not too hot as consumer wore it but closer to the end of the 8 hours max, consumer started to have an uncomfortable pain.Once wrap was removed, consumer noticed a burn blister from where the patch was positioned.Consumer reported to have used this product before and this had never happened, so consumer was quite upset.The pain from the burn was worse than the actual cramps that consumer was experiencing.Upon follow-up, the consumer reported having sent back the "package" asked for.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Additional information received from quality complaint group: summary of investigation: batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister".The cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale:an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.The severity of harm is s3.According to product complaint group on 27aug2020, batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).The return sample evaluation does not show what could have caused a burn or a blister.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister".The cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.Expedite trend assessment rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse.Site sample status: received at the site.On 16oct2020, the product complaint group provided additional details on the return sample evaluation.The return sample evaluation will not change the conclusion.Site sample status: received at the site on 19feb2020.Return sample evaluation: one wrap - wrap evaluation is normal - no defect detected.Cells were soft with brine.One pouch - (l) cm3251 s 09/25, exp aug2022 04:15.Pouch is seal - no defect found.Pouch was opened by the site.One carton - (l) cm3251 09/25, exp aug2022 04:12, carton open by consumer - no defect detected.Confirmed complaint sample defect: no.Reasonably suggest device malfunction: no.Severity of harm: n/a.Follow-up attempts are completed.No further information is expected.Follow-up (04mar2020): new information from a contactable consumer includes: patient sent back the "package;" reporting criteria was updated.Follow-up (10mar2020): new information received from a product quality complaint group includes: thermacare lot number and expiration date, investigation results.Follow-up (27aug2020): new information received from a product complaint group included: investigation result.No follow-up attempts are needed.No further information is expected.Follow-up (06feb2020): no follow-up attempts are needed.No further information expected follow-up (16oct2020): new information received from a product complaint group included: additional details on the return sample evaluation.No follow-up attempts are needed.No further information is expected.
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Manufacturer Narrative
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Additional information received from quality complaint group: summary of investigation: batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister".The cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assmt.& rationale:an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.The severity of harm is s3.According to product complaint group on 27aug2020, batch cm3251 is the only batch within the scope of this investigation.Thermacare 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).The return sample evaluation does not show what could have caused a burn or a blister.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "burn blister".The cause of the consumer stating the wrap caused a burn blister is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.Expedite trend assessment rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse.Site sample status: received at the site.On 16oct2020, the product complaint group provided additional details on the return sample evaluation.The return sample evaluation will not change the conclusion.Site sample status: received at the site on 19feb2020.Return sample evaluation: one wrap - wrap evaluation is normal - no defect detected.Cells were soft with brine.One pouch - (l) cm3251 s 09/25, exp aug2022 04:15.Pouch is seal - no defect found.Pouch was opened by the site.One carton - (l) cm3251 09/25, exp aug2022 04:12, carton open by consumer - no defect detected.Confirmed complaint sample defect: no.Reasonably suggest device malfunction: no.Severity of harm: n/a.
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