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| Lot Number AR5202 |
| Device Problem
Use of Device Problem (1670)
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| Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033)
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| Event Date 10/29/2020 |
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Event Type
Injury
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Event Description
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Event verbatim: terrible rash on her arm/the rash is under the side of her upper arm [rash], she thinks it was the latex part.Maybe she is allergic to it.[rubber sensitivity], hurts/painful [pain], it was red and there is a circle around it.[erythema], it has red dots [rash macular], one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder [device use issue], narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6)-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number: ar5202, expiration date: apr2022, udi#: (b)(4), from 29oct2020 at an unknown frequency for period cramps and a dislocated shoulder.Medical history included ongoing bipolar disorder.Concomitant medication included haloperidol (haldol) 5 mg tablet from (b)(6) 2020, and ongoing, aripiprazole 20 mg tablet from (b)(6) 2020, and ongoing and gabapentin 400 mg capsule and 800 mg tablet from 1992 (started 28 years ago) and ongoing, all for bipolar disorder.For gabapentin, the patient said she got her medication in a pharmacy bottle that was not sealed- she said it was in a bottle where they count out the pills and put it into the pharmacy bottle.She took two formulations because it seemed like they were out of her 800mg tablets to give her enough, so she took a mix so that she still got her correct dose.She took two 400mg capsules and one 800 mg tablet twice a day by mouth for a total of 1600mg twice a day.Grand daily total was 3200mg.The patient stated she used a pfizer product and now she had a terrible rash on arm on (b)(6) 2020.The product was thermacare heat wraps lower back and hip.She originally bought them for her period cramps - it helps with that.She asked, it says not to use if pregnant, is it okay to use when pregnant? she stated she just used the wrap today (b)(4).She just had it on and took it off at about 5pm and now she had a huge rash.It hurts now, but it did not hurt when the wrap was on.She thought it was the latex part.Maybe she was allergic to it.She said she would put neosporin on it.She asked if she should go to a walk in clinic or something.The patient stated she used two of them at the same time, clarifying one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder.She asked if they were okay to use together like that.The patient clarified that the rash was under the side of her upper arm.It was red and there was a circle around it.It had red dots and is 3 inches by 2 inches.It was very painful.She had the wraps on for about 2 hours.The one on her stomach was fine.The patient also got covid test when she was in the hospital about 9 days ago on (b)(6) 2020 with result of negative.The same time when she started her two other medications, haldol and aripiprazole.The patient confirmed that she was in the hospital prior to using the thermacare heat wraps.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 event, "one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder," was unknown, of the other events was not recovered.Additional information has been requested and will be provided as it becomes available.
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Manufacturer Narrative
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Batch ar5202 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), 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 a "terrible rash on arm." the cause of the consumer stated terrible rash on arm 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.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/negligible -minor for this batch.A visual examination was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending cart adverse event negligible minor ar #.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/negligible-minor for lbh product, refer to attachment lbh adverse event negligible-minor (b)(6) 2017 to (b)(6) 2020.A return sample has not been received as of 17nov2020.
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Event Description
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Event verbatim [preferred term].Terrible rash on her arm/the rash is under the side of her upper arm [rash], she thinks it was the latex part.Maybe she is allergic to it.[rubber sensitivity], hurts/painful [pain], it was red and there is a circle around it.[erythema], it has red dots [rash macular], one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder [device use issue], narrative: this is a spontaneous report from a contactable consumer (patient).A 45-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number ar5202, expiration date apr2022, udi#: (b)(4), from (b)(6) 2020 at an unknown frequency for period cramps and a dislocated shoulder.Medical history included ongoing bipolar disorder.Concomitant medication included haloperidol (haldol) 5 mg tablet from (b)(6) 2020 and ongoing, aripiprazole 20 mg tablet from (b)(6) 2020 and ongoing and gabapentin 400 mg capsule and 800 mg tablet from 1992 (started 28 years ago) and ongoing, all for bipolar disorder.For gabapentin, the patient said she got her medication in a pharmacy bottle that was not sealed- she said it was in a bottle where they count out the pills and put it into the pharmacy bottle.She took two formulations because it seemed like they were out of her 800mg tablets to give her enough, so she took a mix so that she still got her correct dose.She took two 400mg capsules and one 800 mg tablet twice a day by mouth for a total of 1600mg twice a day.Grand daily total was 3200mg.The patient stated she used a pfizer product and now she had a terrible rash on arm on (b)(6) 2020.The product was thermacare heat wraps lower back and hip.She originally bought them for her period cramps - it helped with that.She asked, it says not to use if pregnant, is it okay to use when pregnant? she stated she just used the wrap today ((b)(6) 2020).She just had it on and took it off at about 5pm and now she had a huge rash.It hurt now, but it did not hurt when the wrap was on.She thought it was the latex part.Maybe she was allergic to it.She said she would put neosporin on it.She asked if she should go to a walk in clinic or something.The patient stated she used two of them at the same time, clarifying one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder.She asked if they were okay to use together like that.The patient clarified that the rash was under the side of her upper arm.It was red and there was a circle around it.It had red dots and is 3 inches by 2 inches.It was very painful.She had the wraps on for about 2 hours.The one on her stomach was fine.The patient also got covid test when she was in the hospital about 9 days ago on (b)(6) 2020 with result of negative.The same time when she started her two other medications, haldol and aripiprazole.The patient confirmed that she was in the hospital prior to using the thermacare heat wraps.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 event "one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder" was unknown, of the other events was not recovered.According to product quality group: batch ar5202 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), 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 a "terrible rash on arm." the cause of the consumer stated terrible rash on arm 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.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/negligible -minor for this batch.A visual examination was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending cart adverse event negligible minor ar #.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/negligible-minor for lbh product, refer to attachment lbh adverse event negligible-minor (b)(6) 2017 to (b)(6) 2020.A return sample has not been received as of 17nov2020.Follow-up (11nov2020): follow-up attempts completed.No further information expected.Follow-up (19nov2020): new information received from product quality complaint group includes investigation results.Follow-up attempts completed.No further information expected.
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Event Description
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Event verbatim [preferred term], terrible rash on her arm/the rash is under the side of her upper arm [rash], she thinks it was the latex part.Maybe she is allergic to it.[rubber sensitivity], hurts/painful [pain], it was red and there is a circle around it.[erythema], it has red dots [rash macular], one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder [device use issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A 45-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number ar5202, expiration date apr2022, udi#: (b)(4), from (b)(6) 2020 at an unknown frequency for period cramps and a dislocated shoulder.Medical history included ongoing bipolar disorder.Concomitant medication included haloperidol (haldol) 5 mg tablet from (b)(6) 2020 and ongoing, aripiprazole 20 mg tablet from (b)(6) 2020 and ongoing and gabapentin 400 mg capsule and 800 mg tablet from 1992 (started 28 years ago) and ongoing, all for bipolar disorder.For gabapentin, the patient said she got her medication in a pharmacy bottle that was not sealed- she said it was in a bottle where they count out the pills and put it into the pharmacy bottle.She took two formulations because it seemed like they were out of her 800mg tablets to give her enough, so she took a mix so that she still got her correct dose.She took two 400mg capsules and one 800 mg tablet twice a day by mouth for a total of 1600mg twice a day.Grand daily total was 3200mg.The patient stated she used a pfizer product and now she had a terrible rash on arm on (b)(6) 2020.The product was thermacare heat wraps lower back and hip.She originally bought them for her period cramps - it helped with that.She asked, it says not to use if pregnant, is it okay to use when pregnant? she stated she just used the wrap today ((b)(6) 2020).She just had it on and took it off at about 5pm and now she had a huge rash.It hurt now, but it did not hurt when the wrap was on.She thought it was the latex part.Maybe she was allergic to it.She said she would put neosporin on it.She asked if she should go to a walk in clinic or something.The patient stated she used two of them at the same time, clarifying one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder.She asked if they were okay to use together like that.The patient clarified that the rash was under the side of her upper arm.It was red and there was a circle around it.It had red dots and is 3 inches by 2 inches.It was very painful.She had the wraps on for about 2 hours.The one on her stomach was fine.The patient also got covid test when she was in the hospital about 9 days ago on 20oct (b)(6) with result of negative.The same time when she started her two other medications, haldol and aripiprazole.The patient confirmed that she was in the hospital prior to using the thermacare heat wraps.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 event "one on her stomach for her cramps and one on her arm/neck for her dislocated shoulder" was unknown, of the other events was not recovered.According to product quality group: batch ar5202 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), 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 a "terrible rash on arm." the cause of the consumer stated terrible rash on arm 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.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/negligible -minor for this batch.A visual examination was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending cart adverse event negligible minor ar #.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/negligible-minor for lbh product, refer to attachment lbh adverse event negligible-minor (b)(6) 2017 to (b)(6) 2020.A return sample has not been received as of 17nov2020.According to device complaint handling unit (dchu): severity of harm was s3.Follow-up (11nov2020): follow-up attempts completed.No further information expected.Follow-up (19nov2020): new information received from product quality complaint group includes investigation results.Follow-up attempts completed.No further information expected.Follow-up (07jan2021): new information received from device complaint handling unit (dchu) included: severity of harm.Follow-up attempts completed.No further information expected.
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Manufacturer Narrative
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Batch ar5202 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), 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 a "terrible rash on arm." the cause of the consumer stated terrible rash on arm 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.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/negligible -minor for this batch.A visual examination was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to trending cart adverse event negligible minor ar #.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this citi customizable search for the subclasses of adverse event/negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/negligible-minor for lbh product, refer to attachment lbh adverse event negligible-minor (b)(6) 2017 to (b)(6) 2020.A return sample has not been received as of 17nov2020.
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Search Alerts/Recalls
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