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| Lot Number E75529B |
| Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Burning Sensation (2146); Urticaria (2278)
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| Event Date 12/20/2018 |
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Event Type
Injury
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Event Description
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Red rash/rash was from her rear end all the way up back to her neck/ rash spread all over her back [rash erythematous] , raised welts [urticaria] , her back is a little on fire [burning sensation] , she said this must be an allergic reaction [hypersensitivity] , she used the wrap yesterday (on (b)(6) 2018).She said the wrap expired on (b)(6) 2013 [expired device used] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number e75529b, expiration date jun2013, via an unspecified area of administration from (b)(6) 2018 for muscular pain and back was sore/ burning in the middle section of her back.There was no medical history.Concomitant medications included unspecified products.The reporter was calling about the thermacare heatwraps for the back and hip.She said her lower back was out yesterday ((b)(6) 2018) and bothering her, she also had burning in the middle section of her back.She could hardly walk and all of a sudden she hurts so she applied the heatwrap to her muscles to see if it would help.She had the wraps in a drawer for a few years and then she opened one and she used the wrap yesterday (on (b)(6) 2018).She said the wrap expired on (b)(6) 2013 07:16.She used the wrap around her waist.She had the wrap on about 4 to 5 hours, also reported as at least 5 hours.She said the picture shows a man standing with the wrap around the waist.She said the package says powerful pain relief and deep muscle relaxation.On (b)(6) 2018, she went to the chiropractor and lifted her shirt up and was asked what happened to her back.She had rashes and welts on her back.The chiropractor told her to take diphenhydramine (benadryl).She said the rash was from her rear end all the way up back to her neck.She said this looked like measles but with raised welts.She had the wrap on her lower back.This was a red rash with raised welts on her back.She went online and saw the recall and the recent one with menstrual wraps.So she started to think what happened here because she never had this before.She said this must be an allergic reaction because the rash spread all over her back.She said she was unsure if she should go to the emergency room or if this could spread all over her back.She has taken 2 benadryl.She hadn't looked at her back on (b)(6) 2018 because she didn't usually turn around and look at her back.Her daughter took a picture and her back looked the same.The count size was unknown but she had 4 wraps left at moment and all have the same lot and expiration.The rash was on her body and she didn't know if the rash was the same as on (b)(6) 2018 but she didn't notice this until (b)(6) 2018 at 9am while at the chiropractor.The chiropractor called in the nurse and asked did she have shingles.The consumer said she took medications ever day of her life and never had this issue.This was the only new thing that was on her body.She said if this had anything to do with the other medications this would have shown up every night of the week for 25 years.She had no problems until thermacare heatwrap for the back and hip.She said this felt like bad sunburn like if she was out in the sun too long and felt like her back was a little on fire.She said she may take another benadryl which was for allergies and to prevent allergies.She said she looked this up online and this was a heat rash or prickly heat that babies get.She said this was like a heat rash that her daughter would get when she had a fever.She said she has the rash but this has 4-5 welts and raised skin.She said there was a reasonable possibility -100 percent probability that the events were related to the device.She was not currently under the care of a physician for any medical condition.She denied any of the following conditions-diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy.She classified her skin tone as very light or fair.She denied sensitive skin or any abnormal skin conditions.The color of the box purchased was red.There were some products remaining.She only had 1 thermacare used and for 5 hours.She did not use any thermacare before.She previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack), she said years ago she may have used a gel pack either this could be frozen or heated and she used the gel pack as a neck wrap.A sample of the product was available to be returned.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcomes of the events, "she said this must be an allergic reaction," "welts," and "red rash" were not resolved and for other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (14feb2019): follow-up attempts are completed.No further information is expected.Follow-up (21dec2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events rash erythematous, urticaria, burning sensation, and hypersensitivity as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event expired device used is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events rash erythematous, urticaria, burning sensation, and hypersensitivity as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event expired device used is non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term].Red rash/rash was from her rear end all the way up back to her neck/ rash spread all over her back [rash erythematous], raised welts [urticaria], her back is a little on fire [burning sensation], she said this must be an allergic reaction [hypersensitivity], she used the wrap yesterday (on 20dec2018).She said the wrap expired on jun2013 [expired device used].Narrative: this is a spontaneous report from a contactable consumer reporting for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), device lot number e75529b, expiration date jun2013, via an unspecified area of administration from (b)(6) 2018 for muscular pain and back was sore/ burning in the middle section of her back.There was no medical history.Concomitant medications included unspecified products.The reporter was calling about the thermacare heatwraps for the back and hip.She said her lower back was out yesterday (b)(6) 2018 and bothering her, she also had burning in the middle section of her back.She could hardly walk and all of a sudden she hurts so she applied the heatwrap to her muscles to see if it would help.She had the wraps in a drawer for a few years and then she opened one and she used the wrap yesterday (b)(6) 2018.She said the wrap expired on jun2013 07:16.She used the wrap around her waist.She had the wrap on about 4 to 5 hours, also reported as at least 5 hours.She said the picture shows a man standing with the wrap around the waist.She said the package says powerful pain relief and deep muscle relaxation.On (b)(6) 2018, she went to the chiropractor and lifted her shirt up and was asked what happened to her back.She had rashes and welts on her back.The chiropractor told her to take diphenhydramine (benadryl).She said the rash was from her rear end all the way up back to her neck.She said this looked like measles but with raised welts.She had the wrap on her lower back.This was a red rash with raised welts on her back.She went online and saw the recall and the recent one with menstrual wraps.So she started to think what happened here because she never had this before.She said this must be an allergic reaction because the rash spread all over her back.She said she was unsure if she should go to the emergency room or if this could spread all over her back.She has taken 2 benadryl.She hadn't looked at her back on (b)(6) 2018 because she didn't usually turn around and look at her back.Her daughter took a picture and her back looked the same.The count size was unknown but she had 4 wraps left at moment and all have the same lot and expiration.The rash was on her body and she didn't know if the rash was the same as on (b)(6) 2018 but she didn't notice this until (b)(6) 2018 at 9am while at the chiropractor.The chiropractor called in the nurse and asked did she have shingles.The consumer said she took medications ever day of her life and never had this issue.This was the only new thing that was on her body.She said if this had anything to do with the other medications this would have shown up every night of the week for 25 years.She had no problems until thermacare heatwrap for the back and hip.She said this felt like bad sunburn like if she was out in the sun too long and felt like her back was a little on fire.She said she may take another benadryl which was for allergies and to prevent allergies.She said she looked this up online and this was a heat rash or prickly heat that babies get.She said this was like a heat rash that her daughter would get when she had a fever.She said she has the rash but this has 4-5 welts and raised skin.She said there was a reasonable possibility 100 percent probability that the events were related to the device.She was not currently under the care of a physician for any medical condition.She denied any of the following conditions diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy.She classified her skin tone as very light or fair.She denied sensitive skin or any abnormal skin conditions.The color of the box purchased was red.There were some products remaining.She only had 1 thermacare used and for 5 hours.She did not use any thermacare before.She previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack), she said years ago she may have used a gel pack either this could be frozen or heated and she used the gel pack as a neck wrap.A sample of the product was available to be returned.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcomes of the events, "she said this must be an allergic reaction," "welts," and "red rash" were not resolved and for other events was unknown.According to product complaint group, batch e75529 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 the wrap caused rashes and welts on her back.The cause of the consumer stating the wrap caused rashes and welts on her back is inconclusive since review of records does not provide evidence to support a 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.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 safety request for investigation received at the albany site requiring an evaluation for this batch.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.The complaints per million produced (cpmp) result of 3 was below the upper control limit (ucl) of 33.9 for the subclass.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Follow-up (14feb2019): follow-up attempts are completed.No further information is expected.Follow-up (21dec2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (18nov2019): follow-up attempts are completed.No further information is expected.Follow-up (01jul2020): new information received from a product complaint group included: investigation result.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Batch e75529 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 the wrap caused rashes and welts on her back.The cause of the consumer stating the wrap caused rashes and welts on her back is inconclusive since review of records does not provide evidence to support a 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.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 safety request for investigation received at the albany site requiring an evaluation for this batch.Per (b)(4), complaint trending guideline, effective (b)(6) 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.The complaints per million produced (cpmp) result of 3 was below the upper control limit (ucl) of 33.9 for the subclass.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.
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Search Alerts/Recalls
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