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| Lot Number F18501S |
| Device Problems
Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Burn(s) (1757); Hemorrhage/Bleeding (1888)
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| Event Date 06/01/2015 |
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Event Type
Injury
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Manufacturer Narrative
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Company clinical evaluation comment/case comment: based on the information provided, the events thermal burn and hemorrhage as described in this case is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events expired device used and device misuse are assessed as associated with the device user.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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Burned to upper right arm by her shoulder [thermal burn], attached to skin for approximately 16 hours/she did not check her skin under the wrap [device misuse], it bleed though.She describes the bleed as a 10mm blood spot [haemorrhage], expiry date of thermacare neck, shoulder and wrist: 02/2014 [expired device used].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female started to use thermacare heatwrap (thermacare neck, shoulder and wrist), device lot number f18501s, expiration date 02/2014), from an unspecified date in (b)(6) 2015 at an unknown frequency for soreness.Medical history included ongoing high blood pressure.The patient's concomitant medications included alprazolam (azor), via an unspecified route of administration from an unspecified date to an unspecified date at 5/40mg for high blood pressure.The patient previously used thermacare heatwraps and did not experience any burns.The patient reported she used the product two weeks ago.She says she applied the thermacare to her skin, to the right arm near the shoulder at approximately 0800 in the morning and did not remove it until approximately midnight that night.She was at an occasion at her children's house and says she felt something but did not want to get undressed at the occasion.She says that her skin was burned/she experienced a burn to upper right arm, near her shoulder and when she removed the thermacare it bled through in (b)(6) 2015.She described the bleed as a 10mm blood spot.She states that she saw the doctor two days later and the doctor prescribed bacitracin suave and advised the reporter to clean the burn.The action taken with thermacare heatwrap was unknown.She states that the events have resolved at this time.The patient reported her skin tone was very light/fair, her skin was not sensitive and she did not have any abnormal skin conditions.She reported she left the wrap on from 0800 until approximately midnight.The patient previously used a hot water bottle.Thermacare was attached to the skin for approximately 16 hours.The patient did not exercise while wearing the wrap.She did not check her skin under the wrap.She reported she read the instructions prior to use.Additional information has been requested and will be provided as it becomes available.
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Manufacturer Narrative
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No quality issues were identified upon this review of the batch documentation product disposition record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.The product has passed the expiration date of feb2014.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.Four corrective action procedures for individual cell temperature were completed for run day one.Wrap samples were pulled from the same hour of production as the wraps with the out of specification thermal result.The resample wraps met the required temperature specifications.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.The evaluation of the consumer returned sample did not provide any additional information to aid in determining a root cause for the wrap to have caused a burn to the consumer, there were no obvious defects to the returned wrap.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer.An (b)(6) female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: f18501s, expiration date feb2014) from an unspecified date in (b)(6) 2015 at an unknown frequency for soreness and pain.Medical history included ongoing high blood pressure, post-menopausal, heart disease, sensitive to antibiotics and many drugs.The patient's concomitant medications included alprazolam (azor), via an unspecified route of administration from an unspecified date since 5 years ago at 5/40 mg daily for high blood pressure and naproxen sodium (aleve) 220 mg.The patient previously used thermacare heatwraps in 2014 and did not experience any burns.The patient reported she used the product two weeks ago.She says she applied the thermacare to her skin, to the upper right arm near the shoulder at approximately 0800 in the morning and did not remove it until approximately midnight that night.She was at an occasion at her children's house and says she felt something but did not want to get undressed at the occasion.She says that her skin was burned/she experienced a burn to upper right arm, near her shoulder and when she removed the thermacare it bled through in (b)(6) 2015 after wearing thermacare for 8 hours.She describes the bleed as a 10 mm blood spot.She reported she experienced a great deal of pain.She states that she saw the doctor two days later and the doctor prescribed bacitracin suave and advised the reporter to clean the burn.Action taken with thermacare heatwrap was permanently withdrawn on an unspecified date.She states that the events have resolved after 10 days, however she was tender.The patient reported her skin tone was medium, her skin was not sensitive and she did not have any abnormal skin conditions.She reported she left the wrap on for 8 to 10 hours.The patient previously used a hot water bottle, electric heating pad, microwave gel pack in 2012-2013 and did not experience any problems.Thermacare was attached to the skin for approximately 8-10 hours.The patient did not exercise while wearing the wrap.She did check her skin under the wrap (previously reported as she did not check her skin under the wrap).She reported she read the instructions prior to use.Additional information received from product quality complaint (pqc) group provided quality assurance (qa) investigation results.No quality issues were identified upon this review of the batch documentation product disposition record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.The product has passed the expiration date of feb2014.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.Four corrective action procedures for individual cell temperature were completed for run day one.Wrap samples were pulled from the same hour of production as the wraps with the out of specification thermal result.The resample wraps met the required temperature specifications.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.Additional information received from product quality complaint (pqc) group provided quality assurance (qa) investigation results to include returned sample results.The evaluation of the consumer returned sample did not provide any additional information to aid in determining a root cause for the wrap to have caused a burn to the consumer, there were no obvious defects to the returned wrap.Additional information has been requested and will be provided as it becomes available.Follow-up (24jul2015): new information received from a contactable consumer included relevant medical history, concomitant medication data, product data (indication and action taken), reaction data (time of onset and outcome of events).Follow up (13aug2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Follow-up (20oct2015): new information from product quality complaint (pqc) group included: updated qa results to include returned sample results.Follow-up attempts completed.No further information expected company clinical evaluation comment: based on the information provided, the reported events thermal burn together with device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well-being of the user, considered associated with device use.The other events hemorrhage and expired device used are assessed as associated with device.This case meets final 10-day eu and 30-day fda reportability.No quality issues were identified upon this review of the batch documentation product disposition record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.The product has passed the expiration date of feb2014.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.Four corrective action procedures for individual cell temperature were completed for run day one.Wrap samples were pulled from the same hour of production as the wraps with the out of specification thermal result.The resample wraps met the required temperature specifications.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.The evaluation of the consumer returned sample did not provide any additional information to aid in determining a root cause for the wrap to have caused a burn to the consumer, there were no obvious defects to the returned wrap.
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Manufacturer Narrative
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No quality issues were identified upon this review of the batch documentation product disposition record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.The product has passed the expiration date of feb2014.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.Four corrective action procedures for individual cell temperature were completed for run day one.Wrap samples were pulled from the same hour of production as the wraps with the out of specification thermal result.The resample wraps met the required temperature specifications.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.
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Event Description
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Burned to upper right arm by her shoulder [thermal burn].Attached to skin for approximately 8-10 hours/ attached the adhesive to: body [device misuse].It bleed through.She describes the bleed as a 10mm blood spot [haemorrhage].Expiry date of thermacare neck, shoulder & wrist: feb2014 [expired device used].Case description: this is a spontaneous report from a contactable consumer.An (b)(6)-year-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: f18501s, expiration date feb2014) from an unspecified date in (b)(6) 2015 at an unknown frequency for soreness and pain.Medical history included ongoing high blood pressure, post-menopausal, heart disease, sensitive to antibiotics and many drugs.The patient's concomitant medications included alprazolam (azor), via an unspecified route of administration from an unspecified date since 5 years ago at 5/40mg daily for high blood pressure and naproxen sodium (aleve) 220 mg.The patient previously used thermacare heatwraps in 2014 and did not experience any burns.The patient reported she used the product two weeks ago.She says she applied the thermacare to her skin, to the upper right arm near the shoulder at approximately 0800 in the morning and did not remove it until approximately midnight that night.She was at an occasion at her children's house and says she felt something but did not want to get undressed at the occasion.She says that her skin was burned/she experienced a burn to upper right arm, near her shoulder and when she removed the thermacare it bled through in jun2015 after wearing thermacare for 8 hours.She describes the bleed as a 10mm blood spot.She reported she experienced a great deal of pain.She states that she saw the doctor two days later and the doctor prescribed bacitracin suave and advised the reporter to clean the burn.Action taken with thermacare heatwrap was permanently withdrawn on an unspecified date.She states that the events have resolved after 10 days, however she was tender.The patient reported her skin tone was medium, her skin was not sensitive and she did not have any abnormal skin conditions.She reported she left the wrap on for 8 to 10 hours.The patient previously used a hot water bottle, electric heating pad, microwave gel pack in 2012-2013 and did not experience any problems.Thermacare was attached to the skin for approximately 8-10 hours.The patient did not exercise while wearing the wrap.She did check her skin under the wrap (previously reported as she did not check her skin under the wrap).She reported she read the instructions prior to use.Additional information received from product quality complaint (pqc) group provided quality assurance (qa) investigation results.No quality issues were identified upon this review of the batch documentation product disposition record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.The product has passed the expiration date of feb2014.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.Four corrective action procedures for individual cell temperature were completed for run day one.Wrap samples were pulled from the same hour of production as the wraps with the out of specification thermal result.The resample wraps met the required temperature specifications.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2015): new information received from a contactable consumer included relevant medical history, concomitant medication data, product data (indication and action taken), reaction data (time of onset and outcome of events).Follow up ((b)(6) 2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the reported events thermal burn together with device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.The other events hemorrhage and expired device used are assessed as associated with device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the reported events thermal burn together with device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well -being of the user, considered associated with device use.The other events hemorrhage and expired device used are assessed as associated with device.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary: no quality issues were identified upon this review of the batch documentation product disposition record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.The product has passed the expiration date of feb2014.Our manufacturing operations employ quality control procedures which include statistical sampling, thermal testing and visual inspection, to ensure the quality of the product being packaged.Four corrective action procedures for individual cell temperature were completed for run day one.Wrap samples were pulled from the same hour of production as the wraps with the out of specification thermal result.The resample wraps met the required temperature specifications.All procedures were followed, and all criteria met, however, the possibility of this defect occurring is still present.
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Manufacturer Narrative
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Company clinical evaluation comment: based on the information provided, the reported events thermal burn together with device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage of impairment of body structure that can result to deterioration of health and state of well-being of the user, considered associated with device use.The other events hemorrhage and expired device used are assessed as associated with device.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the reported events thermal burn together with device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well-being of the user, considered associated with device use.The other events hemorrhage and expired device used are assessed as associated with device.This case meets follow up 10-day eu and 30-day fda reportability.
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Event Description
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The patient's concomitant medications included alprazolam (azor), via an unspecified route of administration from an unspecified date since 5 years ago at 5/40mg daily for high blood pressure and naproxen sodium (aleve) 220mg.The patient previously used thermacare heatwraps in 2014 and did not experience any burns.The patient reported she used the product two weeks ago.She says she applied the thermacare to her skin, to the upper right arm near the shoulder at approximately 0800 in the morning and did not remove it until approximately midnight that night.She was at an occasion at her children's house and says she felt something but did not want to get undressed at the occasion.She says that her skin was burned she experienced a burn to upper right arm near the shoulder when she removed the thermacare it bled through in (b)(6) 2015 after wearing thermacare for 8 hours.She describes the bleed as a 10mm blood spot.She reported she experienced a great deal of pain.She states she saw the doctor two days later and the doctor prescribed bacitracin suave and advised the reporter to clean the burn.The action taken with thermacare heatwrap was permanently withdrawn on an unspecified date.She states that the events have resolved after 10 days, however she was tender.The patient reported her skin tone was medium, her skin was not sensitive and she did not have any abnormal skin conditions.She reported she left the wrap on for 8 to 10 hours.The patient previously used a hot water bottle, electric heating pad, microwave gel pack in 2012-2013 and did not experience any problems.Thermacare was attached to the skin for approximately 8-10 hours.The patient did not excise while wearing the wrap.She did check her skin under the wrap (previously reported as she did not check her skin under the wrap).She reported she read the instructions prior to use.Additional information has been requested and will be provided as it becomes available.Follow-up (07/24/2015): new information received from a contactable consumer included relevant medical history, concomitant medication data, product data (indication and action taken), reaction data (time of onset and outcome of events).Company clinical evaluation comment: based on the information provided, the reported events thermal burn together with device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well-being of the user, considered associated with device use.The other events hemorrhage and expired device used are assessed as associated with device.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the reported events thermal burn together with device misuse as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure that can result to deterioration of health and state of well-being of the user, considered associated with device use.The other events hemorrhage and expired device used are assessed as associated with device.This case meets follow up 10-day eu and 30-day fda reportability.
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