| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Headache (1880); Pain (1994); Septic Shock (2068); Hot Flashes/Flushes (2153); Chills (2191); Sneezing (2251); Depression (2361); Weight Changes (2607); Nervous System Injury (2689); Eye Pain (4467); Skin Disorders (4543); Injection Site Reaction (4562); Swelling/ Edema (4577)
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| Event Date 01/11/2021 |
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Event Type
Injury
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Event Description
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Nerve damage [nerve injury].Officially depressed [depression].Seriously angry [anger].The skin feels weird on the right side of my face [skin discomfort].Headache [headache].Incredibly numb; entire right side of the face is frozen numb like someone punched me in the face;nose frozen; numbness near cheek, nose, and upper lip when she eats [injection site hypoaesthesia].Freezing; teeth, nose and upper lip are frozen; space between the lip and nose is frozen; cold to touch [feeling cold].Pain in right eye [eye pain].Excruciating pain; pain in laugh lines (from her upper lip to her nose); pain as intermittent [pain].Right nostril feels like it is running; sensation her nose is dripping [rhinorrhoea].When i get upset, my face feels like it is on fire [feeling hot].Lost about five pounds [weight decreased].Swelling [swelling].Bruise; intro orbital bruise [contusion].Severe burning sensation [burning sensation].Hematoma next to nerve [haematoma].Chapping in one spot on her upper lip near the corner [chapped lips].Rha4 for to fill in a sunken face; rha4 in her cheeks --low mid cheek on both sides, on bone both sides at high medial cheek [off label use].United states report received from a consumer on 05-mar-2021 and a physician (injector) on 09-mar-2021.A consumer, who is also the patient, reported that she received rha4 to fill in a sunken face on (b)(6) 2021.The patient reported a volume of 0.5 cc of rha4 was applied to the bilateral inner and outer part of the eyes via a cannula.At this time, the patient also received 1.2 cc of restylane (hyaluronic acid) on the outer edge of the lip and downwards, near the nose, underneath the eyes and between the nose and mouth.The injecting physician reported a volume of 0.5 cc of rha4 was applied with multiple sticks to the low mid cheek on both sides and on bone on both sides at the high medial cheek using 27-gauge needles that came with rha4.It was not reported if a cannula was used for the administration of rha4 to the low mid cheek on both sides and on bone on both sides at the high medial cheek.At that time, the patient also received 1.0 cc of restylane into the perioral areas and marionette lines.Previous cosmetic procedures included a history of approximately 15 years of fillers and historical use of belotero (hyaluronic acid) and restylane (hyaluronic acid).The patient's medical history included occasional alcohol use, a drug allergy to sulfas, reconstructive surgeries, cancer twice(unspecified), intestinal gangrene, and shoulder surgery.Concomitant medications included synthroid (levothyroxine sodium) for hypothyroidism, valacyclovir (valaciclovir hydrochloride) for (b)(6), estrogel (estradiol), and timolol eye drops for migraine.Food supplements were not provided.The patient reported on 11-jan-2021, shortly after the injections, she experienced nerve damage and her face did not feel right, which she further described as feeling incredibly numb, pain in her right eye, a headache, excruciating pain and that the entire right side of her face was frozen numb, like someone had punched her in the face.The injecting physician reported on 11-jan-2021, immediately after injection, he noticed immediate swelling, and the patient reported numbness, a severe burning sensation.The injecting physician reported the needle may have traumatized the nerve and or possibly caused a hematoma with swelling that was putting pressure on the nerve.The patient reported on 14-jan-2021, three days after the rha4 injection, the patient had a follow-up visit with the injector where she received kenalog 10 (triamcinolone acetonide), a lidocaine injection of 0.5 cc at v2, intradermal micro botox (botulinum toxin) and a 5-fu (5-fluorouracil) injection over the affected areas.During that visit, the injector pressed down hard near the patient's nose and eyes and she felt like someone had shot her in the face.The injecting physician reported on 14-jan-2021, three days after the rha4 injection, there was a worsened bruise under the muscle with pain and numbness.The patient reported on 18-jan-2021, one week after the rha4 injection, the patient saw the injecting physician for a second follow-up.No treatments were provided at that time, which was confirmed by the injecting physician.The patient reported on an unknown date in 2021, after the rha4 injection, the patient had an appointment with a neurologist and was scheduled for a nerve conduction test.The patient reported on 03-feb-2021, approximately three weeks after the rha4 injection, the nerve conduction test was performed on both sides of her face and revealed a negative result for nerve damage; no permanent damage was noted.On an unknown date, unspecified laboratory tests were conducted.These results along side the nerve conduction tests results indicated no difference between the sides of the patient's face.They were unable to identify the origin or calibration the severity of the patient's pain.The neurologist clarified that the patient's pain could be multifactorial, including the injection technique, the product, or something else.The patient reported she saw a second neurologist on 12-feb-2021, approximately one month after the rha4 injection, and the patient stated that this second neurologist reported it was possible her nerves short circuited.One neurologist (unknown which one) predicted that resolution may be in weeks to months.By the time the patient saw both neurologists, her symptoms were improving.The injecting physician reported that he asked the patient to come into the office on 04-mar-2021, approximately one month and three weeks after rha4 injection, to offer the patient hyaluronidase to dissolve the dermal fillers, but the patient called to cancel her appointment.The patient reported that on 05-mar-2021, approximately one month and three weeks after rha4 injection, the patient still felt like her "teeth, upper lip, nose and the space between her lip and nose were frozen", "electric shocks", her "right nostril felt like it was running", she was "cold to touch", that the more she talked, the worse her symptoms became, when she "would get upset, her face would feel like it was on fire", her symptoms were worse at night, she had "lost about five pounds", she was "officially depressed", "seriously angry", and "the skin felt weird on the right side of her face".The patient reported that the events were still ongoing but had gotten better.The patient reported that on 09-mar-2021, approximately two months after rha4 injection, her nose was still frozen and was not running as much as before, she was hurting between her nose and lips, she was numb, felt like she had been punched in the face, felt electrical shocks and that her symptoms were worse at night and in the sunlight.The patient reported that she had shoulder and bicep surgery on (b)(6) 2021 and was put on tramadol and ibuprofen 600 milligram two to three times per day for four to five days.The patient additionally reported that was scheduled to receive her first dose of a covid-19 vaccine on 14-mar-2021.The patient did not give consent to contact two neurologists she visited due to the negative findings.On an unknown date, the patient visited a plastic surgeon, of whom was a different physician than the physician who injected the rha, and the patient was injected with an enzyme (likely hyaluronidase) three times for a total of 0.3 cc, in order to break up the filler.The patient stated that she felt the usual pain from the injections as she does based off prior experience with dermal filler injections to her face.The injections were not close to the patient's orbital or other nerves.The surgeon clarified to the patient that the injections of enzyme would not worsen the patient's condition but could improve the patient's pain.The patient clarified that she is unlikely to receive additional injections as her symptoms have improved since treatment.As of 19-mar-2021, the patient clarified that her pain was intermittent, and was noticed only when it returned.The patient further clarified that her pain has improved by 85% but not 100%.Her nose continues to feel cold when she touches it, but not like frostbite.She also stated that she still has the sensation that she feels like her nose is dripping, but tissues are dry after use.The patient further describes continued pain in her laugh lines, from her upper lip to her nose.This pain is relieved by rubbing the area.As of 19-mar-2021, rubbing had not been needed for several days.As of 19-mar-2021, the patient has continued to experience numbness, specifically during eating, and around her cheek, nose, and upper lip.The patient also stated that her mental state was much better, and she does not feel like her life is permanently ruined.On an unknown date, the patient developed chapping on spot on her upper lip, near the corner.A salve was used for treatment.The patient stated she is to have a "facetime" follow-up with her nurse at the surgeon's office on an unknown date in the following week to assess her current status the outcome of the events of nerve injury, skin discomfort, headache, injection site hypoesthesia, feeling cold, eye pain, pain, rhinorrhea, feeling hot, and hematoma was recovering/resolving.The outcome of the events of chapped lips was not recovered/not resolving.The outcome of the events depression, anger, weight decreased, and contusion was not recovered/not resolved.The outcome of the events of swelling and burning sensation was not reported.The product was not available for return.No additional information was available at the time of this report.
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Event Description
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Nerve damage [nerve injury].Officially depressed [depression].Seriously angry [anger].The skin feels weird on the right side of my face [skin discomfort].Headache [headache].Incredibly numb; entire right side of the face is frozen numb like someone punched me in the face;nose frozen; numbness near cheek, nose, and upper lip when she eats [injection site hypoaesthesia].Freezing; teeth, nose and upper lip are frozen; space between the lip and nose is frozen; cold to touch [feeling cold].Pain in right eye [eye pain].Excruciating pain; pain in laugh lines (from her upper lip to her nose); pain as intermittent [pain].Right nostril feels like it is running; sensation her nose is dripping [rhinorrhoea].When i get upset, my face feels like it is on fire [feeling hot].Lost about five pounds [weight decreased].Swelling [swelling].Bruise; intro orbital bruise [contusion].Severe burning sensation [burning sensation].Hematoma next to nerve [haematoma].Chapping in one spot on her upper lip near the corner [chapped lips].Eye swelling [eye swelling].Neuralgia [neuralgia].Rha4 for to fill in a sunken face; rha4 in her cheeks --low mid cheek on both sides, on bone both sides at high medial cheek [off label use].Case description: united states report received from a consumer on (b)(6) 2021 and a physician (injector) on (b)(6) 2021.A consumer, who is also the patient, reported that she received rha4 to fill in a sunken face on (b)(6) 2021.The patient reported a volume of 0.5 cc of rha4 was applied to the bilateral inner and outer part of the eyes via a cannula.At this time, the patient also received 1.2 cc of restylane (hyaluronic acid) on the outer edge of the lip and downwards, near the nose, underneath the eyes and between the nose and mouth.The injecting physician reported a volume of 0.5 cc of rha4 was applied with multiple sticks to the low mid cheek on both sides and on bone on both sides at the high medial cheek using 27-gauge needles that came with rha4.It was not reported if a cannula was used for the administration of rha4 to the low mid cheek on both sides and on bone on both sides at the high medial cheek.At that time, the patient also received 1.0 cc of restylane into the perioral areas and marionette lines.Previous cosmetic procedures included a history of approximately 15 years of fillers and historical use of belotero (hyaluronic acid) and restylane (hyaluronic acid).The patient's medical history included occasional alcohol use, a drug allergy to sulfas, reconstructive surgeries, cancer twice(unspecified), intestinal gangrene, and shoulder surgery.Concomitant medications included synthroid (levothyroxine sodium) for hypothyroidism, valacyclovir (valaciclovir hydrochloride) for herpes, estrogel (estradiol), and timolol eye drops for migraine.Food supplements were not provided.The patient reported on (b)(6) 2021, shortly after the injections, she experienced nerve damage and her face did not feel right, which she further described as feeling incredibly numb, pain in her right eye, a headache, excruciating pain and that the entire right side of her face was frozen numb, like someone had punched her in the face.The injecting physician reported on (b)(6) 2021, immediately after injection, he noticed immediate swelling, and the patient reported numbness, a severe burning sensation.The injecting physician reported the needle may have traumatized the nerve and or possibly caused a hematoma with swelling that was putting pressure on the nerve.The patient reported on (b)(6) 2021, three days after the rha4 injection, the patient had a follow-up visit with the injector where she received kenalog 10 (triamcinolone acetonide), a lidocaine injection of 0.5 cc at v2, intradermal micro botox (botulinum toxin) and a 5-fu (5-fluorouracil) injection over the affected areas.During that visit, the injector pressed down hard near the patient's nose and eyes and she felt like someone had shot her in the face.The injecting physician reported on (b)(6) 2021, three days after the rha4 injection, there was a worsened bruise under the muscle with pain and numbness.The patient reported on (b)(6) 2021, one week after the rha4 injection, the patient saw the injecting physician for a second follow-up.No treatments were provided at that time, which was confirmed by the injecting physician.The patient reported on an unknown date in 2021, after the rha4 injection, the patient had an appointment with a neurologist and was scheduled for a nerve conduction test.The patient reported on (b)(6) 2021, approximately three weeks after the rha4 injection, the nerve conduction test was performed on both sides of her face and revealed a negative result for nerve damage; no permanent damage was noted.On an unknown date, unspecified laboratory tests were conducted.These results along side the nerve conduction tests results indicated no difference between the sides of the patient's face.They were unable to identify the origin or calibration the severity of the patient's pain.The neurologist clarified that the patient's pain could be multifactorial, including the injection technique, the product, or something else.The patient reported she saw a second neurologist on (b)(6) 2021, approximately one month after the rha4 injection, and the patient stated that this second neurologist reported it was possible her nerves short circuited.One neurologist (unknown which one) predicted that resolution may be in weeks to months.By the time the patient saw both neurologists, her symptoms were improving.The injecting physician reported that he asked the patient to come into the office on (b)(6) 2021, approximately one month and three weeks after rha4 injection, to offer the patient hyaluronidase to dissolve the dermal fillers, but the patient called to cancel her appointment.The patient reported that on (b)(6) 2021, approximately one month and three weeks after rha4 injection, the patient still felt like her "teeth, upper lip, nose and the space between her lip and nose were frozen", "electric shocks", her "right nostril felt like it was running", she was "cold to touch", that the more she talked, the worse her symptoms became, when she "would get upset, her face would feel like it was on fire", her symptoms were worse at night, she had "lost about five pounds", she was "officially depressed", "seriously angry", and "the skin felt weird on the right side of her face".The patient reported that the events were still ongoing but had gotten better.The patient reported that on (b)(6) 2021, approximately two months after rha4 injection, her nose was still frozen and was not running as much as before, she was hurting between her nose and lips, she was numb, felt like she had been punched in the face, felt electrical shocks and that her symptoms were worse at night and in the sunlight.The patient reported that she had shoulder and bicep surgery on (b)(6) 2021 and was put on tramadol and ibuprofen 600 milligram two to three times per day for four to five days.The patient additionally reported that was scheduled to receive her first dose of a covid-19 vaccine on (b)(6) 2021.The patient did not give consent to contact two neurologists she visited due to the negative findings.On an unknown date, the patient visited a plastic surgeon, of whom was a different physician than the physician who injected the rha, and the patient was injected with an enzyme (likely hyaluronidase) three times for a total of 0.3 cc, in order to break up the filler.The patient stated that she felt the usual pain from the injections as she does based off prior experience with dermal filler injections to her face.The injections were not close to the patient's orbital or other nerves.The surgeon clarified to the patient that the injections of enzyme would not worsen the patient's condition but could improve the patient's pain.The patient clarified that she is unlikely to receive additional injections as her symptoms have improved since treatment.As of (b)(6) 2021, the patient clarified that her pain was intermittent, and was noticed only when it returned.The patient further clarified that her pain has improved by 85% but not 100%.Her nose continues to feel cold when she touches it, but not like frostbite.She also stated that she still has the sensation that she feels like her nose is dripping, but tissues are dry after use.The patient further describes continued pain in her laugh lines, from her upper lip to her nose.This pain is relieved by rubbing the area.As of 19-mar-2021, rubbing had not been needed for several days.As of (b)(6) 2021, the patient has continued to experience numbness, specifically during eating, and around her cheek, nose, and upper lip.The patient also stated that her mental state was much better, and she does not feel like her life is permanently ruined.On an unknown date, the patient developed chapping on spot on her upper lip, near the corner.A salve was used for treatment.The patient stated she is to have a "facetime" follow-up with her nurse at the surgeon's office on an unknown date in the following week to assess her current status the outcome of the events of nerve injury, skin discomfort, headache, injection site hypoesthesia, feeling cold, eye pain, pain, rhinorrhea, feeling hot, and hematoma was recovering/resolving.The outcome of the events of chapped lips was not recovered/not resolving.The outcome of the events depression, anger, weight decreased, and contusion was not recovered/not resolved.The outcome of the events of swelling and burning sensation was not reported.The product was not available for return.Health effect - clinical code: 4577, swelling/edema.Health effect - clinical code: 2689, nervous system injury.Health effect - clinical code: 2361, depression.Health effect - clinical code: 2068, shock, septic.Health effect - clinical code: 1840, erythema.Health effect - clinical code: 1880, headache.Health effect - clinical code: 4562, injection site reaction.Health effect - clinical code: 2191, chills.Health effect - clinical code: 4467, eye pain.Health effect - clinical code: 1994, pain.Health effect - clinical code: 2251, sneezing.Health effect - clinical code: 2153, hot flashes/flushes.Health effect - clinical code: 2607, weight changes.Health effect - clinical code: 4543, skin disoder.No additional information was available at the time of this report.Follow up report was received on 09-apr-2021 by a healthcare professional.The physician reported that the patient was injected with 0.1cc of rha3 (device changed from initial report) into the right medial superior maxillary bone just lateral to the nasal bone (nasolabial folds and cheeks).The injection technique was reported as bolus and the needle from the box was used.The site of nerve damage was reported as the right infa-orbital nerve.The intensity of nerve damage reported as severe.On 11-jan-2021, the patient experienced eye swelling on the right side and neuralgia in the right infra-orbital nerve.The physician reported that nerve damage, neuralgia and eye swelling were not related to rha3, rather it was from needle trauma with a subsequent submuscular hematoma.The intensity of eye swelling was reported as moderate.The intensity of neuralgia was reported as severe.The outcome of the events eye swelling and neuralgia was recovering/resolving.No additional information was available at the time of this report.
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