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| Lot Number 12J25U0185 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
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| Patient Problems
Burning Sensation (2146); Discomfort (2330); Partial thickness (Second Degree) Burn (2694)
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| Event Date 09/06/2017 |
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Event Type
Injury
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Event Description
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Blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot [burns second degree] , her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up [device use error] , expiry date of thermacare back wrap large/x-large: oct 2005 [expired device used] , didn't seem to work; it wasn't doing much good [device ineffective] , states it was very uncomfortable with the straps that wrapped around.It was too small.[discomfort] ,.Case narrative: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 12j25u0185, expiration date oct2005, on (b)(6) 2017 at an unspecified dose for the sciatic nerve pain in her back.Medical history included rheumatoid arthritis from 2000 and ongoing, had poor circulation with the arthritis, her fingers and toes went numb and she got dead spots in her leg, she stated she could have neuropathy; type 2 diabetes from (b)(6) 2015 and ongoing; basal cell carcinoma from (b)(6) 2017 with treatment, checked by her doctor and told it was eradicated; ongoing sciatic nerve issues; ongoing hypothyroidism; ongoing blood pressure high; ongoing high cholesterol; depression; anxiety; atopic dermitis; eczema; skin allergy.Concomitant medications included methotrexate 2.5 mg tablets, 6 tablets once a week for arthritis; metformin hydrochloride 1000 mg, 1/2 tablet once a day for diabetes; ongoing naproxen 500 mg twice a day for arthritis pain; ongoing folic acid 1 mg once a day as she took methotrexate; ongoing sertraline 1000 mg, two tablets once a day for anti-depression, anti-anxiety; ongoing simvastatin 40 mg, 1/2 tablet once a day for cholesterol; lidocaine hydrochloride (aspercreme with lidocaine); "tapazan" cream.The patient previously used the neck thermacare years ago.It didn't have attachments, they just had stickies.Seven-eight (7-8) years ago she would use neck wraps on her back and neck for arthritis.She would put the thermacare on her neck, cover it in a sweater or a scarf so she could feel the heat and she never got a burn when doing that.The patient previously used heating pad for pain relief on (b)(6) 2017, used it for 20 minutes.She was afraid she was cooking her skin because she used it so much.And she did not experience a problem/symptom with it.The patient previously used amlodipine 5 mg tablet once a day for her blood pressure, she had not been on this for a week or more (in 2017) because her doctor forgot to refill her med.Caller used thermacare back heatwrap on (b)(6) 2017.She put it on in the middle of the day and a couple hours later she took it off because it didn't seem to be working.Only used it for 2-3 hours.It was the first time she had ever used the back heatwrap.It wasn't doing much good so she gave up and took it off.She noticed when she took it off, a spot was red but figured it would go away.Her clothes may have been a little tight on it.She noticed it was really tight.One spot felt like it was hot.When she took it off and looked, it was just a red spot.She figured it would just go away.On (b)(6) 2017 she didn't pay any attention to it.She didn't feel anything.On the morning of (b)(6) 2017 at 01:42, she rolled over and got a burning sensation.She tried to look in the mirror.She could see the red area, just barely.She can barely raise her arms so it was hard for her to see it.She said it was rubbing on her pajama bottoms.She felt it first and it felt like a piece of glad wear or saran wrap but it was attached to her.She tried to pick it but it was her skin.It also reported around 1:30 am on (b)(6) 2017, it had turned into a blister.She rolled over and started having a burning feeling - discovered she has a blister on her left upper butt, it was right in line with her tail bone.Explained she reached back and felt like something that felt like plastic, a really thin piece of saran wrap.She realized it was a blister that had popped.She had some burn relief gel with aloe and tried a little bit of that on it and that burned.She didn't want to put a band-aid on it but it needed to be protected because it's in a place where she couldn't see it.She got her burn gel.She was going to put triple antibiotic cream on it but the she thought, it's a burn.She put the burn cream on it.The cream was called affured burn gel with lidocaine and hydrochloride, a topical analgesic.The patient also reported that she has a burn on her left side upper butt, noticed it at 0142 am on (b)(6) 2017, the blister was still there.She reported the blister was the shape of the dark colored things in the heatwrap, a teardrop type shape.The flesh around where the blister was starting to dry up.While reading the package, she noted that the numbers were faded out.Only has the outside package, stated there were no numbers with the barcode.She did read des-433145.Mentioned the expiration date is near unreadable.She needed glasses and a magnifying glass to read it and to stand by a window with a lot of light.She classified her skin tone as very light or fair.She had sensitive skin.She had abnormal skin conditions included atopic dermitis, eczema, skin allergy- she has to use cetaphil soap and make sure when she has itchy spots, she has to keep lotion on so she doesn't scratch herself to death.She was wearing panties and shorts over it.She was laying down and getting up because she couldn't get comfortable.There was no adhesive- it had straps that wrapped around.States it was very uncomfortable with the straps that wrapped around.It was too small.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare.She did not read the usage instructions on thermacare before you used the product.She was taking her regular medications that she takes everyday.She bought aspercream with lidocaine in it.She was using it on the middle of her lower back, knees and shoulders.She also had tapazan cream, but she didn't use it back there.The one time she did, it caused issues.She did not consult a healthcare professional.She stated that the wrap was in the envelope not in the box.She found the heatwrap in a trailer she just bought.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot was not resolved.The outcome of other events was unknown.The patient considered there was a reasonable possibility that blister was related to the device.Device was available for evaluation.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot", and "her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up" as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events expired device used, device ineffective, and discomfort are considered as non-serious.All events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot", and "her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up" as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events expired device used, device ineffective, and discomfort are considered as non-serious.All events are medically assessed as associated with the use of the device.
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Event Description
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Blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot [burns second degree], her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up [device use error], expiry date of thermacare back wrap large/x-large: oct 2005 [expired device used], didn't seem to work; it wasn't doing much good [device ineffective], states it was very uncomfortable with the straps that wrapped around.It was too small.[discomfort].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number 12j25u0185, expiration date oct2005, on (b)(6) 2017 at an unspecified dose for the sciatic nerve pain in her back.Medical history included rheumatoid arthritis from 2000 and ongoing, had poor circulation with the arthritis, her fingers and toes went numb and she got dead spots in her leg, she stated she could have neuropathy; type 2 diabetes from (b)(6) 2015 and ongoing; basal cell carcinoma from (b)(6) 2017 with treatment, checked by her doctor and told it was eradicated; ongoing sciatic nerve issues; ongoing hypothyroidism; ongoing blood pressure high; ongoing high cholesterol; depression; anxiety; atopic dermatis; eczema; skin allergy.Concomitant medications included methotrexate 2.5mg tablets, 6 tablets once a week for arthritis; metformin hydrochloride 1000mg, 1/2 tablet once a day for diabetes; ongoing naproxen 500mg twice a day for arthritis pain; ongoing folic acid 1mg once a day as she took methotrexate; ongoing sertraline dose 1000 mg, two tablets once a day for anti-depression, anti-anxiety; ongoing simvastatin 40mg, 1/2 tablet once a day for cholesterol; lidocaine hydrochloride ((b)(6) with lidocaine); "tapazan" cream.The patient previously used the neck thermacare years ago.It didn't have attachments, they just had stickies.7-8 years ago she would use neck wraps on her back and neck for arthritis.She would put the thermacare on her neck, cover it in a sweater or a scarf so she could feel the heat and she never got a burn when doing that.The patient previously used heating pad for pain relief on (b)(6) 2017, used it for 20 minutes.She was afraid she was cooking her skin because she used it so much.And she did not experience a problem/symptom with it.The patient previously used amlodipine 5mg tablet once a day for her blood pressure, she had not been on this for a week or more (in 2017) because her doctor forgot to refill her med.Caller used thermacare back heatwrap on (b)(6) 2017.She put it on in the middle of the day and a couple hours later she took it off because it didn't seem to be working.Only used it for 2-3 hours.It was the first time she had ever used the back heatwrap.It wasn't doing much good so she gave up and took it off.She noticed when she took it off, a spot was red but figured it would go away.Her clothes may have been a little tight on it.She noticed it was really tight.One spot felt like it was hot.When she took it off and looked, it was just a red spot.She figured it would just go away.On (b)(6) 2017 she didn't pay any attention to it.She didn't feel anything.On the morning of (b)(6) 2017 at 01:42, she rolled over and got a burning sensation.She tried to look in the mirror.She could see the red area, just barely.She can barely raise her arms so it was hard for her to see it.She said it was rubbing on her pajama bottoms.She felt it first and it felt like a piece of glad wear or saran wrap but it was attached to her.She tried to pick it but it was her skin.It also reported around 1:30am on (b)(6) 2017, it had turned into a blister.She rolled over and started having a burning feeling - discovered she has a blister on her left upper butt, it was right in line with her tail bone.Explained she reached back and felt like something that felt like plastic, a really thin piece of saran wrap.She realized it was a blister that had popped.She had some burn relief gel with aloe and tried a little bit of that on it and that burned.She didn't want to put a (b)(6) on it but it needed to be protected because it's in a place where she couldn't see it.She got her burn gel.She was going to put triple antiobiotic cream on it but the she thought, it's a burn.She put the burn cream on it.The cream was called (b)(6) burn gel with lidocaine and hydrochloride, a topical analgesic.The patient also reported that she has a burn on her left side upper butt, noticed it at 0142am on (b)(6) 2017, the blister was still there.She reported the blister was the shape of the dark colored things in the heatwrap, a teardrop type shape.The flesh around where the blister was starting to dry up.While reading the package, she noted that the numbers were faded out.Only has the outside package, stated there were no numbers with the barcode.She did read des-433145.Mentioned the expiration date is near unreadable.She needed glasses and a magnifying glass to read it and to stand by a window with a lot of light.She classified her skin tone as very light or fair.She had sensitive skin.She had abnormal skin conditions included atopic dermatis, eczema, skin allergy- she has to use cetaphil soap and make sure when she has itchy spots, she has to keep lotion on so she doesn't scratch herself to death.She was wearing panties and shorts over it.She was laying down and getting up because she couldn't get comfortable.There was no adhesive- it had straps that wrapped around.States it was very uncomfortable with the straps that wrapped around.It was too small.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare.She did not read the usage instructions on thermacare before you used the product.She was taking her regular medications that she takes everyday.She bought (b)(6) with lidocaine in it.She was using it on the middle of her lower back, knees and shoulders.She also had tapazan cream, but she didn't use it back there.The one time she did, it caused issues.She did not consult a healthcare professional.She stated that the wrap was in the envelope not in the box.She found the heatwrap in a trailer she just bought.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on 06sep2017.The outcome of blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot was not resolved.The outcome of other events was unknown.The patient considered there was a reasonable possibility that blister was related to the device.Device was available for evaluation.Additional information has been requested and will be provided as it becomes available.Follow-up (11sep2017): new information received from a query response includes: updated sertraline dose.Company clinical evaluation comment: based on the information provided, the events of "blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot", and "her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up" as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events expired device used, device ineffective, and discomfort are considered as non-serious.All events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot", and "her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up" as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events expired device used, device ineffective, and discomfort are considered as non-serious.All 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] blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot [burns second degree] , her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up [device use error] , expiry date of thermacare back wrap large/x-large: oct 2005 [expired device used] , didn't seem to work; it wasn't doing much good [device ineffective] , states it was very uncomfortable with the straps that wrapped around.It was too small.[discomfort] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 64-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number 12j25u0185, expiration date oct2005, on (b)(6) 2017 at an unspecified dose for sciatic nerve pain in lower back.Medical history included rheumatoid arthritis from 2000 and ongoing, had poor circulation with the arthritis, her fingers and toes went numb and she got dead spots in her leg, she stated she could have neuropathy; type 2 diabetes from (b)(6) 2015 and ongoing; basal cell carcinoma from (b)(6) 2017 with treatment, checked by her doctor and told it was eradicated; ongoing sciatic nerve issues; ongoing hypothyroidism; ongoing blood pressure high; ongoing high cholesterol; depression; anxiety; atopic dermatis; eczema; skin allergy and sensitive skin.Concomitant medications included methotrexate 2.5 mg tablets, 6 tablets (15 mg) once a week for arthritis; metformin hydrochloride 1000 mg, 1/2 tablet (500 mg) once a day for diabetes; ongoing naproxen 500 mg twice a day for arthritis pain; ongoing folic acid 1mg once a day as she took methotrexate; ongoing sertraline 1000 mg, two tablets (2000 mg) once a day for anti-depression, anti-anxiety; ongoing simvastatin 40 mg, 1/2 tablet (20 mg) once a day for cholesterol; lidocaine hydrochloride (aspercreme with lidocaine); "tapazan" cream.The patient previously used the neck thermacare years ago.It didn't have attachments, they just had stickies.7-8 years ago she would use neck wraps on her back and neck for arthritis.She would put the thermacare on her neck, cover it in a sweater or a scarf so she could feel the heat and she never got a burn when doing that.The patient previously used heating pad for pain relief on (b)(6) 2017, used it for 20 minutes.She was afraid she was cooking her skin because she used it so much.And she did not experience a problem/symptom with it.The patient previously used amlodipine 5mg tablet once a day for her blood pressure, she had not been on this for a week or more (in 2017) because her doctor forgot to refill her med.The patient used thermacare back heatwrap on (b)(6) 2017.She put it on in the middle of the day and a couple hours later she took it off because it didn't seem to be working.Only used it for 2-3 hours.It was the first time she had ever used the back heatwrap.It wasn't doing much good so she gave up and took it off.She noticed when she took it off, a spot was red but figured it would go away.Her clothes may have been a little tight on it.She noticed it was really tight.One spot felt like it was hot.When she took it off and looked, it was just a red spot.She figured it would just go away.On (b)(6) 2017 she didn't pay any attention to it.She didn't feel anything.On the morning of (b)(6) 2017 at 01:42, she rolled over and got a burning sensation.She tried to look in the mirror.She could see the red area, just barely.She can barely raise her arms so it was hard for her to see it.She said it was rubbing on her pajama bottoms.She felt it first and it felt like a piece of glad wear or saran wrap but it was attached to her.She tried to pick it but it was her skin.It also reported around 1:30am on (b)(6) 2017, it had turned into a blister.She rolled over and started having a burning feeling - discovered she has a blister on her left upper butt, it was right in line with her tail bone.Explained she reached back and felt like something that felt like plastic, a really thin piece of saran wrap.She realized it was a blister that had popped.She had some burn relief gel with aloe and tried a little bit of that on it and that burned.She didn't want to put a bandaid on it but it needed to be protected because it's in a place where she couldn't see it.She got her burn gel.She was going to put triple antiobiotic cream on it but the she thought, it's a burn.She put the burn cream on it.The cream was called affured burn gel with lidocaine and hydrochloride, a topical analgesic.The patient also reported that she had a burn on her left side upper butt, noticed it at 0142am on (b)(6) 2017, the blister was still there.She reported the blister was the shape of the dark colored things in the heatwrap, a teardrop type shape.The flesh around where the blister was starting to dry up.While reading the package, she noted that the numbers were faded out.She only had the outside package, stated there were no numbers with the barcode.She did read des-433145.She mentioned the expiration date was near unreadable.She needed glasses and a magnifying glass to read it and to stand by a window with a lot of light.She classified her skin tone as very light or fair.She had sensitive skin.She had abnormal skin conditions included atopic dermatis, eczema, skin allergy- she had to use cetaphil soap and make sure when she had itchy spots, she had to keep lotion on so she doesn't scratch herself to death.She was wearing panties and shorts over it.She was laying down and getting up because she couldn't get comfortable.There was no adhesive- it had straps that wrapped around.States it was very uncomfortable with the straps that wrapped around on (b)(6) 2017.It was too small.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare on (b)(6) 2017.She did not read the usage instructions on thermacare before she used the product.She was taking her regular medications that she takes everyday.She bought aspercream with lidocaine in it.She was using it on the middle of her lower back, knees and shoulders.She also had tapazan cream, but she didn't use it back there.The one time she did, it caused issues.She did not consult a healthcare professional.She stated that the wrap was in the envelope not in the box.She found the heatwrap in a trailer she just bought.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot was not resolved.The outcome of other events was unknown.The patient considered there was a reasonable possibility that blister was related to the device.Device was available for evaluation.According to the product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass lot# or expiry or manufacturing date is missing/illegible/incorrect conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass lot# or expiry or manufacturing date is missing/illegible/incorrect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Pr state: closed.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Follow-up (11sep2017): new information received from a query response includes: updated sertraline dose.Follow-up (14mar2019): follow-up attempts are completed.No further information is expected.Follow-up (29oct2019): this is a follow-up report received from the product quality complaint group includes investigational results, medical history, concomitant drug dose updated and onset date of event added.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of "blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot", and "her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up" as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events expired device used, device ineffective, and discomfort are considered as non-serious.All events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "blister on her left upper butt/burning feeling/ burning sensation/ one spot felt like it was hot/burned/it's a burn/spot was red/ it was just a red spot", and "her clothes may have been a little tight on it/did not check her skin/did not consult a healthcare professional/ did not read the usage instructions before used/was laying down and getting up" as described were considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events expired device used, device ineffective, and discomfort are considered as non-serious.All events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass lot# or expiry or manufacturing date is missing/illegible/incorrect conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass lot# or expiry or manufacturing date is missing/illegible/incorrect.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Pr state: closed.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.
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Search Alerts/Recalls
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