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| Lot Number CM3251 |
| Device Problems
Use of Device Problem (1670); Excessive Heating (4030)
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| Patient Problems
Fall (1848); Pain (1994); Cramp(s) (2193); Injury (2348)
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| Event Date 04/12/2020 |
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Event Type
Injury
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Event Description
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Getting too hot/it was that hot [device issue], she used the one for the cramps and she just put it on her back/used thermacare heatwrap (thermacare menstrual) for years for her bad back [device use issue], , narrative: this is a spontaneous report from a contactable nurse (patient).An elderly female patient started to use thermacare heatwrap (thermacare menstrual), device lot number cm3251, expiration date aug2022, from an unspecified date at 1 wrap to her back for the day for back pain.Medical history included allergies to medications, colon cancer, blood clots, irregular heartbeat, all from an unknown date and unknown if ongoing.Concomitant medication included sotalol for irregular heartbeat, rabeprazole sodium (aciphex), acetylsalicylic acid (aspirin), ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (centrum silver), calcitriol (oscal), hydroxocobalamin (vitamin b12), losartan and docusate sodium (colace).The patient had used thermacare heatwrap (thermacare menstrual) for years for her bad back lifting too many big patients.The patient was a retired registered nurse.She was calling about thermacare heatwraps menstrual therapy.She stated she used the one for the cramps and she just put it on her back.She noticed that when she put it on (b)(6) 2020 that the stones weren't firm they were like gravel, they were really soft and within half an hour she had to take it off; it was that hot.Prior to taking it off she put extra layers on.She put on a urinary pad, tucked her shirt in and then her underpants, were all used as extra layers and she still had to take it off.The patient stated she used the product on (b)(6) 2020, took a break on (b)(6) 2020 from anything, used the ointment on (b)(6) 2020.She tried to use the product again today on (b)(6) 2020 but the same thing happened with it getting too hot and she had to take it off again.She said the stones felt different was what caught her eye, clarifying the way it was wrapped and packaged were the same.The patient stated she had an endoscopy and a colonoscopy and she noticed that she had more gas, so she cut her aciphex dose down since she had been on that for years.It brought the gas down.When she called her gi doctor about it, he agreed with her decreasing the dose.She noticed that if she ate country trail mix with raisins, mixed nuts, dry cranberry and crunchy cereal, she didn't need the colace anymore.It went right through her.She wanted to quit taking it but would wait until she saw her doctor to discuss that.The patient also said her height was down due to her back and for her weight, she said she didn't want to be (b)(6) wanted to be (b)(6) pounds.It was because she had to stay in the house and couldn't go to her fitness thing.The patient stated that in (b)(6) 2020 she fell at church when she was doing blood pressures at the (city name).Her hands were full and she fell and bounced down 3 stairs on her bottom.It took her 6 weeks before she could sit.She couldn't sit on anything but a hard seat.The sample of the product was available to be returned.The action taken in response to the events for the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available., comment: this complaint too hot for thermacare menstrual is reportable due to serious injury necessitates medical intervention to preclude permanent damage to a body structure.The event device use issue is non-serious.The events are associated with use of device.
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Manufacturer Narrative
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Batch cm3251 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reports the wrap too hot.The cause of the consumer stating the wrap was too hot 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 risk of skin irritation.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 subclass wrap/patch/pad too hot received at the (name) site requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for menstrual 8hr products for this lot.Site sample status was not received.
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Event Description
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Event verbatim [preferred term]: getting too hot/it was that hot [device issue].She used the one for the cramps and she just put it on her back/used thermacare.Heatwrap (thermacare menstrual) for years for her bad back [device use issue].Narrative: this is a spontaneous report from a contactable nurse (patient).An elderly female patient started to use thermacare heatwrap (thermacare menstrual), device lot number cm3251, expiration date aug2022, from an unspecified date at 1 wrap to her back for the day for back pain.Medical history included allergies to medications, colon cancer, blood clots, irregular heartbeat.Concomitant medication included sotalol for irregular heartbeat, rabeprazole sodium (aciphex), acetylsalicylic acid (aspirin), ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (centrum silver), calcitriol (oscal), hydroxocobalamin (vitamin b12), losartan and docusate sodium (colace).The patient had used thermacare heatwrap (thermacare menstrual) for years for her bad back lifting too many big patients.The patient was a retired registered nurse.She was calling about thermacare heatwraps menstrual therapy.She stated she used the one for the cramps and she just put it on her back.She noticed that when she put it on (b)(6) 2020 that the stones weren't firm they were like gravel, they were really soft and within half an hour she had to take it off; it was that hot.Prior to taking it off she put extra layers on.She put on a urinary pad, tucked her shirt in and then her underpants, were all used as extra layers and she still had to take it off.The patient stated she used the product on (b)(6) 2020, took a break on (b)(6) 2020 from anything, used the ointment on (b)(6) 2020.She tried to use the product again today on (b)(6) 2020 but the same thing happened with it getting too hot and she had to take it off again.She said the stones felt different was what caught her eye, clarifying the way it was wrapped and packaged were the same.The patient stated she had an endoscopy and a colonoscopy and she noticed that she had more gas, so she cut her aciphex dose down since she had been on that for years.It brought the gas down.When she called her gi doctor about it, he agreed with her decreasing the dose.She noticed that if she ate country trail mix with raisins, mixed nuts, dry cranberry and crunchy cereal, she didn't need the colace anymore.It went right through her.She wanted to quit taking it but would wait until she saw her doctor to discuss that.The patient also said her height was down due to her back and for her weight, she said she didn't want to be 130 wanted to be 129 pounds.It was because she had to stay in the house and couldn't go to her fitness thing.The patient stated that in feb2020 she fell at church when she was doing blood pressures at the (city name).Her hands were full and she fell and bounced down 3 stairs on her bottom.It took her 6 weeks before she could sit.She couldn't sit on anything but a hard seat.The sample of the product was available to be returned.The action taken in response to the events for the product was unknown.The outcome of the events was unknown.According to product quality complaint group, batch cm3251 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reports the wrap too hot.The cause of the consumer stating the wrap was too hot 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 risk of skin irritation.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 subclass wrap/patch/pad too hot received at the (name) site requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for menstrual 8hr products for this lot.Site sample status was not received.Follow-up (29apr2020): follow-up attempts completed.No further information is expected.Follow-up (08jun2020): new information received from a product quality complaint group included: investigation result.Follow-up attempts are completed.No further information is expected.
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Event Description
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Event verbatim [preferred term].Getting too hot/it was that hot [device issue], she used the one for the cramps and she just put it on her back/used thermacare heatwrap (thermacare menstrual) for years for her bad back [device use error], , narrative: this is a spontaneous report from a contactable nurse (patient).An elderly female patient started to use thermacare heatwrap (thermacare menstrual), device lot number cm3251, expiration date aug2022, from an unspecified date at 1 wrap to her back for the day for back pain.Medical history included allergies to medications, colon cancer, blood clots, irregular heartbeat, had more gas, height was down and fell in (b)(6) 2020.Concomitant medication included sotalol for irregular heartbeat, rabeprazole sodium (aciphex), acetylsalicylic acid (aspirin), ascorbic acid, betacarotene, biotin, calcium, chromium, cholecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (centrum silver), calcitriol (oscal), hydroxocobalamin (vitamin b12), losartan and docusate sodium (colace).The patient had used thermacare heatwrap (thermacare menstrual) for years for her bad back lifting too many big patients.The patient was a retired registered nurse.She was calling about thermacare heatwraps menstrual therapy.She stated she used the one for the cramps and she just put it on her back.She noticed that when she put it on (b)(6) 2020 that the stones weren't firm they were like gravel, they were really soft and within half an hour she had to take it off; it was that hot.Prior to taking it off she put extra layers on.She put on a urinary pad, tucked her shirt in and then her underpants, were all used as extra layers and she still had to take it off.The patient stated she used the product on (b)(6) 2020, took a break on (b)(6) 2020 from anything, used the ointment on (b)(6) 2020.She tried to use the product again today on (b)(6) 2020 but the same thing happened with it getting too hot and she had to take it off again.She said the stones felt different was what caught her eye, clarifying the way it was wrapped and packaged were the same.The patient stated she had an endoscopy and a colonoscopy and she noticed that she had more gas, so she cut her aciphex dose down since she had been on that for years.It brought the gas down.When she called her gi doctor about it, he agreed with her decreasing the dose.She noticed that if she ate country trail mix with raisins, mixed nuts, dry cranberry and crunchy cereal, she didn't need the colace anymore.It went right through her.She wanted to quit taking it but would wait until she saw her doctor to discuss that.The patient also said her height was down due to her back and for her weight, she said she didn't want to be 130 wanted to be 129 pounds.It was because she had to stay in the house and couldn't go to her fitness thing.The patient stated that in (b)(6) 2020 she fell at church when she was doing blood pressures at the (city name).Her hands were full and she fell and bounced down 3 stairs on her bottom.It took her 6 weeks before she could sit.She couldn't sit on anything but a hard seat.The sample of the product was available to be returned.The action taken in response to the events for the product was unknown.The outcome of the events was unknown.According to product quality complaint group, 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.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reports the wrap too hot.The cause of the consumer stating the wrap was too hot 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 risk of skin irritation.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 subclass wrap/patch/pad too hot received at the (name) site requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for menstrual 8hr products for this lot.Site sample status was received at the site.Return sample evaluation: one wrap - wrap shows evidence of wear.Cell packs are hard; evidence of brine dosing - no obvious defects.Also returned 3 pantiliners 2 were in packaging - one was stuck to the body side of the wrap.Severity of harm was s3.Follow-up (29apr2020): follow-up attempts completed.No further information is expected.Follow-up (08jun2020): new information received from a product quality complaint group included: investigation result.Follow-up attempts are completed.No further information is expected.Follow-up (01sep2020): new information received from a product quality complaint group included sample received at the site, severity of harm was s3.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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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.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reports the wrap too hot.The cause of the consumer stating the wrap was too hot 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 risk of skin irritation.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 subclass wrap/patch/pad too hot received at the (name) site requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Expend trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for menstrual 8hr products for this lot.Site sample status was received at the site.Return sample evaluation: one wrap - wrap shows evidence of wear.Cell packs are hard; evidence of brine dosing - no obvious defects.Also returned 3 pantiliners 2 were in packaging - one was stuck to the body side of the wrap.Severity of harm was s3.
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Event Description
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Event verbatim [preferred term] getting too hot/it was that hot [device issue], she used the one for the cramps and she just put it on her back/used thermacare heatwrap (thermacare menstrual) for years for her bad back [device use issue], , narrative: this is a spontaneous report from a contactable nurse (patient).An elderly female patient started to use thermacare heatwrap (thermacare menstrual), device lot number cm3251, expiration date aug2022, from an unspecified date at 1 wrap to her back for the day for back pain.Medical history included allergies to medications, colon cancer, blood clots, irregular heartbeat, had more gas, height was down and fell in (b)(6) 2020.Concomitant medication included sotalol for irregular heartbeat, rabeprazole sodium (aciphex), acetylsalicylic acid (aspirin), ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (centrum silver), calcitriol (oscal), hydroxocobalamin (vitamin b12), losartan and docusate sodium (colace).The patient had used thermacare heatwrap (thermacare menstrual) for years for her bad back lifting too many big patients.The patient was a retired registered nurse.She was calling about thermacare heatwraps menstrual therapy.She stated she used the one for the cramps and she just put it on her back.She noticed that when she put it on (b)(6) 2020 that the stones weren't firm they were like gravel, they were really soft and within half an hour she had to take it off; it was that hot.Prior to taking it off she put extra layers on.She put on a urinary pad, tucked her shirt in and then her underpants, were all used as extra layers and she still had to take it off.The patient stated she used the product on (b)(6) 2020, took a break on (b)(6) 2020 from anything, used the ointment on (b)(6) 2020.She tried to use the product again today on (b)(6) 2020 but the same thing happened with it getting too hot and she had to take it off again.She said the stones felt different was what caught her eye, clarifying the way it was wrapped and packaged were the same.The patient stated she had an endoscopy and a colonoscopy and she noticed that she had more gas, so she cut her aciphex dose down since she had been on that for years.It brought the gas down.When she called her gi doctor about it, he agreed with her decreasing the dose.She noticed that if she ate country trail mix with raisins, mixed nuts, dry cranberry and crunchy cereal, she didn't need the colace anymore.It went right through her.She wanted to quit taking it but would wait until she saw her doctor to discuss that.The patient also said her height was down due to her back and for her weight, she said she didn't want to be 130 wanted to be 129 pounds.It was because she had to stay in the house and couldn't go to her fitness thing.The patient stated that in (b)(6) 2020 she fell at church when she was doing blood pressures at the (city name).Her hands were full and she fell and bounced down 3 stairs on her bottom.It took her 6 weeks before she could sit.She couldn't sit on anything but a hard seat.The sample of the product was available to be returned.The action taken in response to the events for the product was unknown.The outcome of the events was unknown.According to product quality complaint group, 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.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reports the wrap too hot.The cause of the consumer stating the wrap was too hot 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 risk of skin irritation.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 subclass wrap/patch/pad too hot received at the (name) site requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for menstrual 8hr products.Refer to the 36-month trend chart attachment menstrual wrap too hot (b)(6) 2017 to (b)(6) 2020.There is no further action required.There was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 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 received at the site.Return sample evaluation: one wrap - wrap shows evidence of wear.Cell packs are hard; evidence of brine dosing - no obvious defects.Also returned 3 pantiliners 2 were in packaging - one was stuck to the body side of the wrap.Severity of harm was s3.Follow-up (29apr2020): follow-up attempts completed.No further information is expected.Follow-up (08jun2020): new information received from a product quality complaint group included: investigation result.Follow-up attempts are completed.No further information is expected.Follow-up (01sep2020): new information received from a product quality complaint group included sample received at the site, severity of harm was s3.Follow-up attempts are completed.No further information is expected.Follow-up (12oct2020): new information received from a product quality complaint group included: updated expedite trend.
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Manufacturer Narrative
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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.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reports the wrap too hot.The cause of the consumer stating the wrap was too hot 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 risk of skin irritation.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 subclass wrap/patch/pad too hot received at the (name) site requiring an evaluation for this batch.On this basis, a trend does not exist for this batch.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass wrap/patch/pad too hot for menstrual 8hr products.Refer to the 36-month trend chart attachment menstrual wrap too hot (b)(6) 2017 to (b)(6) 2020.There is no further action required.There was deviation from sop-105746, complaint trending guidelines, effective (b)(6) 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 received at the site.Return sample evaluation: one wrap - wrap shows evidence of wear.Cell packs are hard; evidence of brine dosing - no obvious defects.Also returned 3 pantiliners 2 were in packaging - one was stuck to the body side of the wrap.
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Search Alerts/Recalls
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