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| Lot Number X96230 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Rash (2033); Discomfort (2330); Impaired Healing (2378); Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Event Description
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She got blisters and rash from thermacare wrap on her stomach [blister], rash from thermacare wrap on her stomach [rash], she got the product for back pain and it gave her worse pain on her stomach [abdominal pain upper], felt sick in her stomach, like sunstroke.She commented that it was weird [gastric disorder], uncomfortable [discomfort].Case narrative:this is a spontaneous report from a contactable consumer reporting on herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back and hip) lot number x96230 expiry date jul2021, from an unspecified date for back pain.The patient medical history and concomitant medications were not reported.The patient reported that she got blisters and rash from thermacare wrap on her stomach.She got the product for back pain and it gave her worse pain on her stomach.She honestly felt sick in her stomach, like sunstroke.She commented that it was weird.She was very upset about the rash as it looked so unsightly and was very uncomfortable.She thought she would have to go to doctor as it was not healing.The patient stated that the wrap worked well for her back however caused a reaction on her stomach.She had never had an allergic reaction before and said it actually made her feel ill looking at the rash.In the end hydrocortisone cream cleared the rash, however only after a period of time.The action taken for the product was unknown.The outcome of the event rash was resolved, the outcome of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "got blisters and rash from thermacare wrap on her stomach/she got the product for back pain and it gave her worse pain on her stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "honestly felt sick in her stomach, like sunstroke/ was very uncomfortable" are non-serious.The events are associated with use of device.Comment: based on the information provided, the events of "got blisters and rash from thermacare wrap on her stomach/she got the product for back pain and it gave her worse pain on her stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "honestly felt sick in her stomach, like sunstroke/ was very uncomfortable" are non-serious.The events are associated with use of device.
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Event Description
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Event verbatim [preferred term]: she got blisters and rash from thermacare wrap on her stomach [blister], rash from thermacare wrap on her stomach [rash] , she got the product for back pain and it gave her worse pain on her stomach [abdominal pain upper] , felt sick in her stomach, like sunstroke.She commented that it was weird [gastric disorder] , uncomfortable [discomfort].Case narrative:this is a spontaneous report from a contactable consumer reporting on herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back and hip) lot number x96230; expiry date jul2021, from an unspecified date for back pain.The patient medical history and concomitant medications were not reported.The patient reported that she got blisters and rash from thermacare wrap on her stomach.She got the product for back pain and it gave her worse pain on her stomach.She honestly felt sick in her stomach, like sunstroke.She commented that it was weird.She was very upset about the rash as it looked so unsightly and was very uncomfortable.She thought she would have to go to doctor as it was not healing.The patient stated that the wrap worked well for her back however caused a reaction on her stomach.She had never had an allergic reaction before and said it actually made her feel ill looking at the rash.In the end hydrocortisone cream cleared the rash, however only after a period of time.The action taken for the product was unknown.The outcome of the event rash was resolved, the outcome of the other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (11feb2020): this is a follow-up report combining information from duplicate reports 2020042726 and 2020027736.The current and all subsequent follow-up information will be reported under manufacturer report number 2020042726.Company clinical evaluation comment based on the information provided, the events of "got blisters and rash from thermacare wrap on her stomach/she got the product for back pain and it gave her worse pain on her stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "honestly felt sick in her stomach, like sunstroke/ was very uncomfortable" are non-serious.The events are associated with use of device., comment: based on the information provided, the events of "got blisters and rash from thermacare wrap on her stomach/she got the product for back pain and it gave her worse pain on her stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "honestly felt sick in her stomach, like sunstroke/ was very uncomfortable" are non-serious.The events are associated with use of device.
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Event Description
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Event verbatim [preferred term]; she got blisters and rash from thermacare wrap on her stomach [blister].Rash from thermacare wrap on her stomach [rash].She got the product for back pain and it gave her worse pain on her stomach [abdominal pain upper].Felt sick in her stomach, like sunstroke.She commented, that it was weird [gastric disorder] , uncomfortable [discomfort].Case narrative: this is a spontaneous report from a contactable consumer reporting on herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back and hip) lot number x96230, expiry date jul2021, from an unspecified date for back pain.The patient medical history and concomitant medications were not reported.The patient reported, that she got blisters and rash from thermacare wrap on her stomach.She got the product for back pain, and it gave her worse pain on her stomach.She honestly felt sick in her stomach, like sunstroke.She commented ,that it was weird.She was very upset about the rash as it looked so unsightly and was very uncomfortable.She thought she would have to go to doctor as it was not healing.The patient stated, that the wrap worked well for her back.However, caused a reaction on her stomach.She had never had an allergic reaction before.And said it actually made her feel ill looking at the rash.In the end hydrocortisone cream cleared the rash.However, only after a period of time.The action taken for the product was unknown.The outcome of the event rash was resolved on an unspecified date.The outcome of the other events was unknown.According to the product quality complaint group on 07mar2020: 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 i got blisters & rash from termacare wrap on my stomach.The cause of the consumer stating, the wrap caused blisters and rash 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 is not received.Severity of harm is s3.Follow-up (11feb2020): this is a follow-up report combining information from duplicate reports 2020042726 and 2020027736.The current and all subsequent follow-up information will be reported under manufacturer report number 2020042726.Follow-up (07mar2020): new information received from product quality complaint group includes investigation results.Comment: based on the information provided, the events of "got blisters and rash from thermacare wrap on her stomach/she got the product for back pain and it gave her worse pain on her stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "honestly felt sick in her stomach, like sunstroke/ was very uncomfortable" are non-serious.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.Product effect varies with each individual.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap, caused i got blisters & rash from termacare wrap on my stomach.The cause of the consumer stating, the wrap caused blisters and rash 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 is not received.
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Event Description
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Event verbatim [preferred term] she got blisters and rash from thermacare wrap on her stomach [blister], rash from thermacare wrap on her stomach [rash], she got the product for back pain and it gave her worse pain on her stomach [abdominal pain upper], felt sick in her stomach, like sunstroke.She commented that it was weird/ she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area [gastric disorder] , uncomfortable [discomfort].Case narrative:this is a spontaneous report from a contactable consumer reporting on herself.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back and hip) (device lot number x96230, expiry date jul2021) from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.The patient reported that she got blisters and rash from thermacare wrap on her stomach.She got the product for back pain and it gave her worse pain on her stomach.She honestly felt sick in her stomach, like sunstroke.She commented that it was weird.She was very upset about the rash as it looked so unsightly and was very uncomfortable.She thought she would have to go to doctor as it was not healing.The patient stated that the wrap worked well for her back however caused a reaction on her stomach.She had never had an allergic reaction before and said it actually made her feel ill looking at the rash.In the end hydrocortisone cream cleared the rash, however only after a period of time.The patient further stated she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area.She took photos.She said it was so weird to get a product for your back (from lifting weights gym problem).She would have been better off with back pain.The patient stated the sickness was like sun stroke, clarifying she had waves of it like morning sickness when you were pregnant.She would never forget it.She would say it was the only reaction she had even got from any product.She said she was not over sensitive in mind or body but felt very strongly about this reaction.She meant to say there was no need for this.She said she might try and get a stick on back pad and get rid of belt on heat wrap.She had been to doctor with rash all over her body since this and was told she had the same problem with the product.So she was not alone.She could not wear her regular clothes for about two weeks as her stomach was too bad.So the product made her so sick.The action taken for the product was unknown.The outcome of the event rash was resolved on an unspecified date.The outcome of the other events was unknown.According to the product quality complaint group on (b)(6) 2020: 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 i got blisters & rash from termacare wrap on my stomach.The cause of the consumer stating the wrap caused blisters and rash 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 is not received.Severity of harm is s3.As of (b)(6) 2020, no other similar events or other ae's have been reported for this lot number.Follow-up (11feb2020): this is a follow-up report combining information from duplicate reports (b)(4).The current and all subsequent follow-up information will be reported under manufacturer report number (b)(4).Follow-up (07mar2020): new information received from product quality complaint group includes investigation results.Follow up (18mar2020): new information received from the same contactable consumer includes: additional reaction data (she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area), event details and clinical course details.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of "got blisters and rash from thermacare wrap on her stomach/she got the product for back pain and it gave her worse pain on her stomach" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events of "honestly felt sick in her stomach, like sunstroke/ was very uncomfortable" are non-serious.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.Product effect varies with each individual.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions 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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused i got blisters & rash from termacare wrap on my stomach.The cause of the consumer stating the wrap caused blisters and rash 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 is not received.
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Event Description
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Event verbatim [preferred term], she got blisters and rash from thermacare wrap on her stomach [blister], rash from thermacare wrap on her stomach [rash], she got the product for back pain and it gave her worse pain on her stomach [abdominal pain upper], felt sick in her stomach, like sunstroke.She commented that it was weird/ she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area [gastric disorder], uncomfortable [discomfort], , narrative: this is a spontaneous report from a contactable consumer reporting on herself.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back and hip) (device lot number x96230, expiry date jul2021) from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.The patient reported that she got blisters and rash from thermacare wrap on her stomach.She got the product for back pain and it gave her worse pain on her stomach.She honestly felt sick in her stomach, like sunstroke.She commented that it was weird.She was very upset about the rash as it looked so unsightly and was very uncomfortable.She thought she would have to go to doctor as it was not healing.The patient stated that the wrap worked well for her back however caused a reaction on her stomach.She had never had an allergic reaction before and said it actually made her feel ill looking at the rash.In the end hydrocortisone cream cleared the rash, however only after a period of time.The patient further stated she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area.She took photos.She said it was so weird to get a product for your back (from lifting weights gym problem).She would have been better off with back pain.The patient stated the sickness was like sun stroke, clarifying she had waves of it like morning sickness when you were pregnant.She would never forget it.She would say it was the only reaction she had even got from any product.She said she was not over sensitive in mind or body but felt very strongly about this reaction.She meant to say there was no need for this.She said she might try and get a stick on back pad and get rid of belt on heat wrap.She had been to doctor with rash all over her body since this and was told she had the same problem with the product.So she was not alone.She could not wear her regular clothes for about two weeks as her stomach was too bad.So the product made her so sick.The action taken for the product was unknown.The outcome of the event rash was resolved on an unspecified date.The outcome of the other events was unknown.As of 02mar2020, no other similar events or other ae's have been reported for this lot number.According to the product quality complaint group on 07mar2020 and 13oct2020: severity of harm was s3.Batch x96230 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 " i got blisters & rash from thermacare wrap on my stomach." the cause of the consumer stating the wrap caused blisters and rash 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 and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass adverse event/serious/unknown for lbh 8hr products.Refer to the attached trending chart lbh adverse event serious unknown 19-jan-2017 to 19-jan-2020.There is no further action required.There was deviation from (b)(4), complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status was not received.According to product quality complaint group on 16oct2020: summary of investigation: batch x96230 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 as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wrap caused "rash and blisters." the cause of the consumer reporting wrap caused rash and blisters is inconclusive.The review of records does not provide evidence to support the 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 second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.The previous investigations did not confirm to have a manufacturing root cause related to the subclass.Per (b)(4) compliant trending guideline, effective date: 24 feb 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.Per (b)(4), a visual examination was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this lot.Refer to attachment x96230 adverse event serious unknown.Lot trend actions taken: no trend identified in this batch.Exped trend assmt.& 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 no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh adverse event/serious/unknown 18-mar-2017 to 18-mar-2020.Exped trend actions taken: there was deviation from (b)(4), complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status: not received.Follow-up (11feb2020): this is a follow-up report combining information from duplicate reports 2020042726 and 2020027736.The current and all subsequent follow-up information will be reported under manufacturer report number 2020042726.Follow-up (07mar2020): new information received from product quality complaint group includes investigation results.Follow up (18mar2020): new information received from the same contactable consumer includes: additional reaction data (she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area), event details and clinical course details.Follow-up attempts are completed.No further information is expected.Follow-up (13oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.Follow-up (16oct2020): new information received from the product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Batch x96230 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 " i got blisters & rash from thermacare wrap on my stomach." the cause of the consumer stating the wrap caused blisters and rash 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 and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass adverse event/serious/unknown for lbh 8hr products.Refer to the attached trending chart lbh adverse event serious unknown 19-jan-2017 to 19-jan-2020.There is no further action required.There was deviation from (b)(4), complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status was not received.Summary of investigation: batch x96230 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 as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wrap caused "rash and blisters." the cause of the consumer reporting wrap caused rash and blisters is inconclusive.The review of records does not provide evidence to support the 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 second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.The previous investigations did not confirm to have a manufacturing root cause related to the subclass.Per sop 105746 compliant trending guideline, effective date: 24 feb 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.Per (b)(4), a visual examination was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this lot.Refer to attachment x96230 adverse event serious unknown.Lot trend actions taken: no trend identified in this batch.Exped trend assmt.& 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 no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh adverse event/serious/unknown 18-mar-2017 to 18-mar-2020.Exped trend actions taken: there was deviation from (b)(4), complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Site sample status: not received.
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Event Description
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Event verbatim [preferred term] she got blisters and rash from thermacare wrap on her stomach [blister], rash from thermacare wrap on her stomach [rash], she got the product for back pain and it gave her worse pain on her stomach [abdominal pain upper], felt sick in her stomach, like sunstroke.She commented that it was weird/ she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area [gastric disorder], uncomfortable [discomfort], , narrative: this is a spontaneous report from a contactable consumer reporting on herself.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back and hip) (device lot number x96230, expiry date jul2021) from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.The patient reported that she got blisters and rash from thermacare wrap on her stomach.She got the product for back pain and it gave her worse pain on her stomach.She honestly felt sick in her stomach, like sunstroke.She commented that it was weird.She was very upset about the rash as it looked so unsightly and was very uncomfortable.She thought she would have to go to doctor as it was not healing.The patient stated that the wrap worked well for her back however caused a reaction on her stomach.She had never had an allergic reaction before and said it actually made her feel ill looking at the rash.In the end hydrocortisone cream cleared the rash, however only after a period of time.The patient further stated she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area.She took photos.She said it was so weird to get a product for your back (from lifting weights gym problem).She would have been better off with back pain.The patient stated the sickness was like sun stroke, clarifying she had waves of it like morning sickness when you were pregnant.She would never forget it.She would say it was the only reaction she had even got from any product.She said she was not over sensitive in mind or body but felt very strongly about this reaction.She meant to say there was no need for this.She said she might try and get a stick on back pad and get rid of belt on heat wrap.She had been to doctor with rash all over her body since this and was told she had the same problem with the product.So she was not alone.She could not wear her regular clothes for about two weeks as her stomach was too bad.So the product made her so sick.The action taken for the product was unknown.The outcome of the event rash was resolved on an unspecified date.The outcome of the other events was unknown.As of 02mar2020, no other similar events or other ae's have been reported for this lot number.According to the product quality complaint group: severity of harm was s3.Batch x96230 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 " i got blisters & rash from thermacare wrap on my stomach." the cause of the consumer stating the wrap caused blisters and rash 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 and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass adverse event/serious/unknown for lbh 8hr products.Refer to the attached trending chart lbh adverse event serious unknown 19-jan-2017 to 19-jan-2020.There is no further action required.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.Site sample status was not received.Follow-up (11feb2020): this is a follow-up report combining information from duplicate reports 2020042726 and 2020027736.The current and all subsequent follow-up information will be reported under manufacturer report number 2020042726.Follow-up (07mar2020): new information received from product quality complaint group includes investigation results.Follow up (18mar2020): new information received from the same contactable consumer includes: additional reaction data (she was so sick from the rash and then blisters she got from the belt part of the wrap that went around the stomach area), event details and clinical course details.Follow-up attempts are completed.No further information is expected.Follow-up (13oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Batch x96230 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 " i got blisters & rash from thermacare wrap on my stomach." the cause of the consumer stating the wrap caused blisters and rash 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 and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, no trend identified for the subclass adverse event/serious/unknown for lbh 8hr products.Refer to the attached trending chart lbh adverse event serious unknown 19-jan-2017 to (b)(6) 2020.There is no further action required.There was deviation from sop-105746, complaint trending guidelines, effective 24-feb-2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-5283155, action item pr-5283193.Site sample status was not received.
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