Model Number N/A |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problems
Erythema (1840); Headache (1880); Nerve Damage (1979); Pain (1994); Hot Flashes/Flushes (2153); Sneezing (2251); Numbness (2415); Nervous System Injury (2689); Swelling/ Edema (4577)
|
Event Date 01/11/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional information have been queried for clarification.Local reactions including pain, erythema, numbness, nerve compression, hematoma, heat sensation immediately or within days after injection are well-known and documented adverse reactions following injections of hyaluronic acid fillers.They are related to the traumatic environment of the injection, vary according to injection volume and technique and patient factors, they are usually of spontaneous resolution or resolve quickly with appropriate medical treatment.Moreover, the risk of such reactions is mentioned in the instruction for use of teosyal products.
|
|
Event Description
|
The case occurred in the united states.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.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.No visual disturbance was reported.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.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 (b)(6) 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.
|
|
Manufacturer Narrative
|
Local reactions including pain, erythema, numbness, nerve compression, hematoma, heat sensation immediately or within days after injection are well-known and documented adverse reactions following injections of hyaluronic acid fillers.They are related to the traumatic environment of the injection, vary according to injection volume and technique and patient factors, they are usually of spontaneous resolution or resolve quickly with appropriate medical treatment.Moreover, the risk of such reactions is mentioned in the instruction for use of teosyal products.
|
|
Event Description
|
The case occurred in the united states.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.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.No visual distrubance was reported.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.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 (b)(6) 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 follow up report was received on (b)(6) 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 (b)(6) 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 neuralgia and eye swelling was recovering/resolving.No additional information was available at the time of this report.
|
|
Manufacturer Narrative
|
This case seems related to a nerve irritation following the injection procedure.This reaction remains very rare but is well documented in the context of hyaluronic acid filler injections.This can be due an accidental injection in or near a nerve, triggering its compression; an excessive massage of the injected area or as suggested by the injector in this case, to the needle trauma.This reaction is accompanied with tingling, numbness, pain, hematoma, which are also well-known and widely documented reactions in the context of hyaluronic acid filler injections.In this case, they are linked to the traumatic environment of the procedure and the nerve irritation, and are transitory.In addition, the risk of such reactions is mentioned in the instructions for use of teosyal products.
|
|
Event Description
|
This case occurred in the united states.According to the received information, the patient was injected with 0,5 ml of teosyal rha3 in the low mid cheek and high cheek on both sides on (b)(6) 2021.At that time, the patient also received 1ml of restylane into the perioral areas and marionette lines.On (b)(6) 2021, immediately after injection, the reporter noticed immediate swelling, and the patient reported numbness, excruciating pain, headache and a severe burning sensation.The injector suspected a neuralgia and supposed the needle may have traumatized the nerve and or possibly caused a hematoma with swelling that was putting pressure on the nerve.No visual disturbance was reported.On (b)(6) 2021, the patient had a follow-up visit with the injector and the latter reported a worsened bruising under the muscle, pain and numbness.She received kenalog 10 (triamcinolone acetonide), a lidocaine injection (0.5 cc) , intradermal micro botox (botulinum toxin) and a 5-fu (5-fluorouracil) injection over the affected areas.During that visit, the patient reported that the injector pressed down hard near the patient's nose and eyes and she felt like someone had shot her in the face.On (b)(6) 2021, the patient saw the injecting physician for a second follow-up.No treatments were provided at that time.On an unknown date in 2021, the patient had an appointment with a neurologist and was scheduled for a nerve conduction test.On (b)(6) 2021, 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 consulted a second neurologist on (b)(6) 2021, and stated that this second neurologist reported it was possible her nerves short circuited.One of the neurologists consulted predicted that resolution may be in weeks to months.By this time,the patient's symptoms were improving.The injecting physician reported that he asked the patient to come into the office on (b)(6) 2021, to offer hyaluronidase to dissolve the dermal fillers, but the patient called to cancel her appointment.On (b)(6) 2021, the patient reported that she still had a freezing sensation in the top of her lip ,tingling, and that the more she talked, the worse her symptoms became.Also, when she "would get upset, her face would feel like it was on fire" and her symptoms were worse at night.The patient reported that the events were still ongoing on date of (b)(6) 2021 but had gotten better.On an unknown date, the patient visited a plastic surgeon who injected the patient with an enzyme (likely hyaluronidase) three times for a total of 0.3 cc, in order to remove the filler.The patient stated feeling the usual pain from the injections.The injections were not close to the patient's orbital or other nerves.The patient confirmed her symptoms 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.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 (b)(6) 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.On an unknown date, the patient developed chapping on spot on her upper lip, near the corner.A salve was used for treatment.On (b)(6) 2021, all symptoms were resolving.The injector reported that symptoms were not related to rha3, but rather to needle trauma with a subsequent submuscular hematoma.
|
|
Search Alerts/Recalls
|
|