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| Lot Number M59543 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Scarring (2061); Swelling (2091); Burning Sensation (2146); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Burn, Thermal (2530); Limited Mobility Of The Implanted Joint (2671)
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| Event Date 02/28/2016 |
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Event Type
Injury
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Event Description
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Looking terrible (burn)/feels burning sensation/burned her back in three places, swelling on her back, pain, /her butt burns up (with the product).[thermal burn].Blisters.She could not sleep and she cannot even sit and leaned up [sleep disorder].[mobility decreased].It was not helping [device ineffective].Her back was scarred.Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient.Started to receive thermacare heatwrap (thermacare lower back & hip) , device lot number m59543 , expiration date sep2018 , from (b)(6) 2016 for an unspecified indication.Medical history included blood pressure abnormal from an unknown date and blood pressure is fine now.Concomitant medication included lisinopril at 10 mg, one per day for blood pressure.The patient put it on around 7 am in the morning and by 7:30 on (b)(6) 2016, she feels burning sensation and she reached work like 8 o'clock and then she took it off and there was nothing so she put it back on.Consumer bought thermacare heatwrap and results were not good.She mentioned that results wasn't wonderful and added that it was not helping.She went to her doctor and her doctor told her to give a call to (b)(4) as it was looking terrible.She filled a prescription of a cream silver sulfadiazine 1% and she need to apply it when it burns.She refills it the morning on (b)(6) 2016 but she hasn't use the cream yet.She mentioned that it still burns.Because of that she couldn't sleep and she can't even sit and leaned up.The patient got burn and blisters on (b)(6) 2016, the product burnt her back, she was feeling pain because her back was burnt and she went to the doctor.She had visited the doctor and she got some cream to put over it but it was very tender, so she could not put that on her back.She encountered a burned back in three places.She had gone to the doctor two times.She still had swelling on her back.Her back was scarred (in (b)(6) 2016).She also reported her butt burns up with the product and her butt is sore.No lab test.She mentioned that there were no cuts, tears, leaks or holes on wrap.She did not modify or change the wrap, she just put it on.She did not put that in microwave.She did not wear it while sleeping and added that she wear it in morning over a light blouse.She used it over her lower part of her back.She did not exercise she was just walking.She did not apply any pressure.She wears one clothing before, then wrap, then one clothing over the wrap.She did not use more than one wrap in a day.Device was stopped on (b)(6) 2016.The outcome of the events blisters and back was scarred was unknown, the outcome of the other events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(4) 2016): new information reported from the same contactable consumer included: new events (blisters, she was feeling pain because her back was burnt, swelling on her back, her back was scarred, her butt burns up with the product and her butt is sore).Company clinical evaluation comment: based on the information provided, the events thermal burn and blister as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events sleep disorder, mobility decreased, scar, and device ineffective are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn and blister as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events sleep disorder, mobility decreased, scar, and device ineffective are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer.A (b)(6) other (b)(6) english female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: m59543, expiration date: sep2018) from (b)(6) 2016 for an unspecified indication.Medical history included blood pressure abnormal from an unknown date and blood pressure is fine now.Concomitant medication included lisinopril at 10 mg, one per day for blood pressure.The patient put it on around 7 am in the morning and by 7:30 on (b)(6) 2016, she felt burning sensation.She reached work like 8 o'clock and then she took it off and there was nothing so she put it back on.The patient bought thermacare heatwrap and the results were not wonderful and added that it was not helping.She went to her doctor and her doctor told her to give a call to pfizer as it was looking terrible.She filled a prescription of a cream silver sulfadiazine 1% and she need to apply it when it burns.She refilled it the morning of (b)(6) 2016 but she hasn't use the cream yet.She mentioned that it stills burns because of that she couldn't sleep and she can't even sit or lean up.The patient got burn and blisters on (b)(6) 2016, the product burned her back, she was feeling pain because her back was burned and she went to the doctor.She visited the doctor and she got some cream to apply but it was very tender, so she could not put that on her back.She experienced a burned back in three places.She had gone to the doctor two times.She still had swelling on her back.Her back was scarred (in (b)(6) 2016).She also reported her butt burns up with the product and her butt is sore.No lab tests were performed.She mentioned that there were no cuts, tears, leaks or holes on wrap.The patient did not modify or change the wrap, she just put it on.She did not put the wrap in the microwave.The patient did not wear it while sleeping and added that she wore it in the morning over a light blouse.She used it over her lower part of her back and did not exercise, she was just walking.The patient did not apply any pressure over the heatwrap.She wears one clothing before, then wrap, then one clothing over the wrap.The patient did not use more than one wrap in a day.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.The outcome of the events blisters and back was scarred was unknown, the outcome of the other events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (04mar2016, 07mar2016, 09mar2016 and 10mar2016): new information reported from the same contactable consumer included: new events (blisters, she was feeling pain because her back was burnt, swelling on her back, her back was scarred, her butt burns up with the product and her butt is sore).Case has been upgraded to serious on follow-up received.Follow-up (07apr2016): this contactable consumer reported by way of consumer questionnaire.This female patient purchased thermacare heatwraps (thermacare lower back and hip) (expiration date: sep2018 at 21:14) on (b)(6) 2016 and used on (b)(6) 2016 for 4 hours for pain in her lower back.The relevant medical history included mild arthritis and eye trouble on an unknown date.On (b)(6) 2016, after using thermacare heatwrap, the patient developed burning which was diagnosed as second degree burn.She was treated with silver sulfadiazine, mupirocin ointment and triamcinolone acetonide ointment for second degree burn.As of 07apr2016, the clinical outcome of the event second degree burn was unknown.Follow-up (21apr2016): this contactable consumer reported by way of consumer follow-up questionnaire.This female patient used thermacare heatwrap (thermacare lower back & hip) over clothing on (b)(6) 2016 for pain in her lower back and hip.The relevant medical history included cholesterol (patient was under physician care) and blood pressure (patient was under physician care and treated with lisinopril since an unknown date) on an unknown date.The concomitant medication included lisinopril since an unknown date.On (b)(6) 2016, after using thermacare heatwraps she was looking terrible (burn)/feels burning sensation/burned her back in three places, swelling on her back, pain/her butt burns up (with the product)/burns on her back and blisters.She was treated with silver sulfadiazine and triamcinolone for the event looking terrible (burn)/feels burning sensation/burned her back in three places, swelling on her back, pain/her butt burns up (with the product)/burns on her back.She received unknown treatment for the event she could not sleep and she cannot event sit and leaned up and it was not helping.She was also treated with mupirocin, desoximetasone (topicort) ointment 0.05% and used cocoa butter for the event her back was scarred.It was reported that her symptoms pain and scar were still remained.As of (b)(6) 2016, the clinical outcome of the events second degree burn and her back was scarred was not recovered.
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Event Description
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Second degree burn [burns second degree], she could not sleep and she cannot even sit and leaned up [sleep disorder], she could not sleep and she cannot even sit and leaned up [mobility decreased], it was not helping [device ineffective], her back was scarred [scar].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) other (b)(6) english female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: m59543, expiration date: sep2018) from (b)(6) 2016 for an unspecified indication.Medical history included blood pressure abnormal from an unknown date and blood pressure is fine now.Concomitant medication included lisinopril at 10 mg, one per day for blood pressure.The patient put it on around 7 am in the morning and by 7:30 on (b)(6) 2016, she felt burning sensation.She reached work like 8 o'clock and then she took it off and there was nothing so she put it back on.The patient bought thermacare heatwrap and the results were not wonderful and added that it was not helping.She went to her doctor and her doctor told her to give a call to pfizer as it was looking terrible.She filled a prescription of a cream silver sulfadiazine 1% and she need to apply it when it burns.She refilled it the morning of (b)(6) 2016 but she hasn't use the cream yet.She mentioned that it stills burns because of that she couldn't sleep and she can't even sit or lean up.The patient got burn and blisters on (b)(6) 2016, the product burned her back, she was feeling pain because her back was burned and she went to the doctor.She visited the doctor and she got some cream to apply but it was very tender, so she could not put that on her back.She experienced a burned back in three places.She had gone to the doctor two times.She still had swelling on her back.Her back was scarred (in (b)(6) 2016).She also reported her butt burns up with the product and her butt is sore.No lab tests were performed.She mentioned that there were no cuts, tears, leaks or holes on wrap.The patient did not modify or change the wrap, she just put it on.She did not put the wrap in the microwave.The patient did not wear it while sleeping and added that she wore it in the morning over a light blouse.She used it over her lower part of her back and did not exercise, she was just walking.The patient did not apply any pressure over the heatwrap.She wears one clothing before, then wrap, then one clothing over the wrap.The patient did not use more than one wrap in a day.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.The outcome of the events blisters and back was scarred was unknown, the outcome of the other events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (04mar2016, 07mar2016, 09mar2016 and 10mar2016): new information reported from the same contactable consumer included: new events (blisters, she was feeling pain because her back was burnt, swelling on her back, her back was scarred, her butt burns up with the product and her butt is sore).Case has been upgraded to serious on follow-up received.Follow-up (07apr2016): this contactable consumer reported by way of consumer questionnaire.This female patient purchased thermacare heatwraps (thermacare lower back and hip) (expiration date: sep2018 at 21:14) on (b)(6) 2016 and used on (b)(6) 2016 for 4 hours for pain in her lower back.The relevant medical history included mild arthritis and eye trouble on an unknown date.On (b)(6) 2016, after using thermacare heatwrap, the patient developed burning which was diagnosed as second degree burn.She was treated with silver sulfadiazine, mupirocin ointment and triamcinolone acetonide ointment for second degree burn.As of 07apr2016, the clinical outcome of the event second degree burn was unknown.
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Manufacturer Narrative
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The new information received from investigation report included on (b)(6) 2016 that the thermacare heatwrap (thermacare lower back & hip) manufacture date was (b)(6) 2015.The sample was not requested by the company.On (b)(6) 2016, visual inspection of retain samples which included five cartons, ten pouches and the ten wraps inside from batch m59543 was performed which showed no obvious defects.The plant reviewed the batch from a manufacturing and technical perspective.No quality issues were identified upon the review of batch records, release testing data or, inspection of retained samples.There were no known site investigations associated with the batch.Retained samples met the product description and the product was within expiration date.After a review of the batch thermal records, all thermal results met product release criteria.The review of the batch device history record for the lot concluded all release requirements were met.Review of the manufacturing attributes and variables quality checks associated with the batch indicated that all required in process inspections were performed and all inspection criteria was met.Thermal data for the five day manufacturing run included a total of 120 wraps tested for individual cell temperature, wrap average temperature and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.Consumer alleged burn from wrap.The cause of the alleged burn was inconclusive since review of records did not provide evidence to support defective product.The product effect may vary with each individual.It was reported that further investigation was not required.Final confirmation status was reported as not confirmed.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer.A (b)(6) year-old other (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: m59543, expiration date: (b)(6) 2018) from (b)(6) 2016 for an unspecified indication.Medical history included blood pressure abnormal from an unknown date and blood pressure is fine now.Concomitant medication included lisinopril at 10 mg, one per day for blood pressure.The patient put it on around 7 am in the morning and by 7:30 on (b)(6) 2016, she felt burning sensation.She reached work like 8 o'clock and then she took it off and there was nothing so she put it back on.The patient bought thermacare heatwrap and the results were not wonderful and added that it was not helping.She went to her doctor and her doctor told her to give a call.Follow-up ((b)(6) 2016): the new information received from investigation report included on (b)(6) 2016 that the thermacare heat wrap (thermacare lower back & hip) manufacture date was (b)(6) 2015.The sample was not requested by the company.On (b)(6) 2016, visual inspection of retain samples which included five cartons, ten pouches and the ten wraps inside from batch m59543 was performed which showed no obvious defects.The plant reviewed the batch from a manufacturing and technical perspective.No quality issues were identified upon the review of batch records, release testing data or, inspection of retained samples.There were no known site investigations associated with the batch.Retained samples met the product description and the product was within expiration date.After a review of the batch thermal records, all thermal results met product release criteria.The review of the batch device history record for the lot concluded all release requirements were met.Review of the manufacturing attributes and variables quality checks associated with the batch indicated that all required in process inspections were performed and all inspection criteria was met.Thermal data for the five day manufacturing run included a total of 120 wraps tested for individual cell temperature, wrap average temperature and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.Consumer alleged burn from wrap.The cause of the alleged burn was inconclusive since review of records did not provide evidence to support defective product.The product effect may vary with each individual.It was reported that further investigation was not required.Final confirmation status was reported as not confirmed.Evaluation summary.The new information received from investigation report included on (b)(6) 2016 that the thermacare heatwrap (thermacare lower back & hip) manufacture date was (b)(6) 2015.The sample was not requested by the company.On (b)(6) 2016, visual inspection of retain samples which included five cartons, ten pouches and the ten wraps inside from batch m59543 was performed which showed no obvious defects.The plant reviewed the batch from a manufacturing and technical perspective.No quality issues were identified upon the review of batch records, release testing data or, inspection of retained samples.There were no known site investigations associated with the batch.Retained samples met the product description and the product was within expiration date.After a review of the batch thermal records, all thermal results met product release criteria.The review of the batch device history record for the lot concluded all release requirements were met.Review of the manufacturing attributes and variables quality checks associated with the batch indicated that all required in process inspections were performed and all inspection criteria was met.Thermal data for the five day manufacturing run included a total of 120 wraps tested for individual cell temperature, wrap average temperature and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.Consumer alleged burn from wrap.The cause of the alleged burn was inconclusive since review of records did not provide evidence to support defective product.The product effect may vary with each individual.It was reported that further investigation was not required.Final confirmation status was reported as not confirmed.
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Search Alerts/Recalls
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