|
|
| Lot Number UNKNOWN |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
|
| Patient Problems
Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Paralysis (1997); Discomfort (2330); Deformity/ Disfigurement (2360); Numbness (2415); Subcutaneous Nodule (4548); Easy Bruising (4558); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
| Event Date 04/09/2021 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Company comment: the serious events of mass and oedema at implant site, and the non-serious events of hypersensitivity, pain, hypoaesthesia, bruising and infection at implant site, discomfort at injection site, device dislocation, nerve injury, facial paralysis, cutaneous contour deformity, paraesthesia, headache and poor peripheral circulation were considered expected and possibly related to the treatment.Seriousness criteria include the need for multiple medical interventions to prevent the permanent damage.The potential root cause include treatment procedure.Potential contributory factor include injection technique.The events of hypoaesthesia at implant site and paraesthesia could be secondary to nerve injury due to dislocation of product and facial paralysis due to mass and oedema at implant site.Alternative root cause for the events paraesthesia, headache and facial paralysis include concomitant toxin treatment.The case meets the criteria for expedited reporting to the regulatory authorities.Product notes: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Facial paralysis; cutaneous contour deformity.
|
| |
|
Event Description
|
|
Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2022 by a female patient (unknown age) reporting her own case.Additional information was received on (b)(6) 2022 from the patient herself.No information about history of allergies has been provided.The patient had previously received treatment with 1ml restylane volyme and 1 ml juvederm voluma with lidocaine to cheekbones.After this treatment, she experienced a blue and smaller lump under the left eye that disappeared after about two months (b)(4).On (b)(6) 2021, the patient received treatment with approximately 2 ml restylane, 0.8 ml to each side of the cheekbones and 0.2 ml to each side of the middle face (unknown lot number, injection technique and needle type).The same day, the patient also received treatment with small amount of botox [botulinum toxin type a] to forehead.On (b)(6) 2021, the patient started to feel distinct rock-hard sausage-shaped lumps (implant site mass) and began to swollen/ swelling/edema/fluid (implant site oedema) due to an allergic reaction (implant site hypersensitivity).From (b)(6) 2021 to (b)(6) 2021 , the patient could not remember event course details but swelling and tenderness/pain/sore (implant site pain) started to progress slowly.On (b)(6) 2021 , the patient's left cheekbone had become twice the size.There was proper swelling and whole face was very tender.A video chat with initial treating nurse was conducted.The left lump, which was the largest, had migrated and was now located close to the eye.On (b)(6) 2021 , the patient met with treating nurse and received the first dose of cortisone [cortisone], 8 tablets, at 4.30 p.M.Thereafter, she was very swollen and tender, and she could not touch the face without having pain in all muscles.Then she developed an edema in the form of a fluid-filled bag under the eye unclear which side the bag was located on at that point.She was still swollen and sore later in the evening but noticed a very small difference.On (b)(6) 2021 in the morning, the patient took 6 cortisone tablets.The swelling had become little smaller and little less painful.The lumps were still the same, equally hard and large.The patient was still swollen under the eye.She had a strange feeling, like a tingling sensation (paraesthesia) in the scalp and head.The patient had described it like when a numb arm wakes up but not as strong.She had no fever, redness or direct heat on the cheek but she felt a little under the weather/frozen and a little dull.She could not do anything physically demanding.On (b)(6) 2021 , the patient took 3 cortisone tablets.She was less swollen, the bag under the eye was smaller but the lumps were still the same.She experienced a little more pain in the face again on the right side.On this side, the lump had also moved slightly upwards.She also had more swelling on the lower part of the left side of the face.She had a headache (headache) and was tired which also could have been due to dehydration and poor sleep.After taking the paracetamol [paracetamol], she felt stronger and more alert and even thought about going for a slow paced run the next day.Late in the evening, she started massaging the lumps quite hard and intensely.On (b)(6) 2021 , the patient woke up more swollen than ever probably due to the lump massage last evening.Now there was edema also in the left corner of the eye.She got a new round of cortisone prescribed by physician and took 5 tablets in the afternoon.The patient visited her general practitioner, who did an infection test which turned out to be negative.In the evening, she felt like the nose was numb (implant site hypoaesthesia), a bit like having poor blood supply (poor peripheral circulation).On (b)(6) 2021 , the patient took 5 cortisone tablets.The swelling had subsided but not as much as last time.The edema was slightly smaller in the morning but increased during the day.She felt rigid in the face when she woke up and could not move the muscles.This subsided later.The nose was no longer numb.The patient visited the clinic for ultrasound and consultation.On (b)(6) 2021 , the patient took 5 cortisone tablets.She was still swollen and tender, but better.On (b)(6) 2021 , the patient took 5 cortisone tablets.She visited the clinic to dissolve the fillers with hyalase [hyaluronidase] and took another 6 tablets of cortisone after treatment in the afternoon.She was not very swollen with regard to treatment, perhaps due to high dose cortisone.The left lump was approximately half as large in the evening and right lump was almost gone.On (b)(6) 2021 , the patient took 2 cortisone tablets in the afternoon.She was not very swollen but there was still sore on the left side.The right side, where the smaller lump had been located, felt strange when she touched it like touching a nerve that had got a bit irritated (maybe by the treatment).On (b)(6) 2021 , the patient took 1 cortisone tablet in the morning and 2 in the afternoon.Otherwise, the day was like the previous day.She started treatment with kavepenin [phenoxymethylpenicillin potassium].On (b)(6) 2021 , the treatment with cortisone was stopped.She felt like the penicillin had some effect.The left lump was a little smaller and the uncomfortable feeling/tightness (injection site discomfort) in the cheek had subsided a bit.On (b)(6) 2021 , the status of the patient was as before, but now there was also fluid under the right eye.The patient went to another clinic for injection of more dissolving enzyme.The patient had increasingly felt as if the left lump under the eye had almost grown into the eye bone, sitting very hard against the bone and also around the eye bone she felt like the lump was the largest.Otherwise, the lump had decreased quite a lot.She also felt a tightness in her face, such as reduced mobility.The patient had returned once to the clinic who performed the second hyalase treatment for further hyalase treatment on the left side of her nose because she felt an unpleasant tingling sensation there and suspected that the restylane had migrated (device dislocation) there.The patient reported that the filler intended for the middle face in fact ended up in the nasolabial folds for an unknown reason.She also visited the initial treating nurse a couple of times to dissolve restylane that had migrated to under the right eye and seemed to be the cause of the swelling there.She also had residues of restylane in the cheekbones dissolved.The patient had further stated that the swelling under the right eye never disappeared.For a few months, she regularly (maybe once a month) experienced a bruise (implant site bruising) on the cheek.In connection with this, the swelling decreased slightly.When the bruise disappeared, after about a week, the swelling returned.In the recent months, the swelling had become worse and more widespread.She had recurrent outbreaks of really swollen lumps under the right eye.According to patient, she got less and less muscle control on the right side, where she seems to have suffered a nerve damage (nerve injury) after the intensive massage of restylane lumps in connection with the hyalase dissolution.In (b)(6) 2021 , the patient suddenly could not use the muscles.She started using nuface [tretinoin] treatment that stimulates something using microcurrent.She received a little better contact with the muscles but she felt that the face was hanging on the right side (facial paralysis).In 2022, the patient had visited two different injecting nurses.In addition, she revisited the clinic who performed the first dissolution.The therapists had concluded that the patient has restylane left under the right eye which was probably pressing on the lymph and that possibly a biofilm (implant site infection) has been developed.They also concluded that patient had very hollow under the eyes (cutaneous contour deformity).The patient also stated that she had very distinct nasolabial folds after dissolving the lumps.Outcome at the time of the report: rock-hard sausage-shaped lumps was recovered/resolved with sequelae.Swollen/swelling/edema/fluid was not recovered/not resolved/ongoing.Allergic reaction was recovered/resolved.Tenderness/pain/sore was unknown.Strange feeling, like a tingling sensation was unknown.Headache was unknown.Numb was recovered/resolved.Uncomfortable feeling/tightness was recovering/resolving.Restylane had migrated was unknown.Bruise was recovered/resolved.Poor blood supply was unknown.Nerve damage was not recovered/not resolved/ongoing.Biofilm was unknown.Face was hanging on the right side was unknown.Very hollow under the eyes was unknown.
|
| |
|
Event Description
|
|
Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2022 by a female patient (unknown age) reporting her own case.Additional information was received on (b)(6) 2022 from the patient herself.No information about history of allergies has been provided.The patient had previously received treatment with 1ml restylane volyme and 1 ml juvederm voluma with lidocaine to cheekbones.After this treatment, she experienced a blue and smaller lump under the left eye that disappeared after about two months (case (b)(4)).On (b)(6) 2021, the patient received treatment with approximately 2 ml restylane, 0.8 ml to each side of the cheekbones and 0.2 ml to each side of the middle face (unknown lot number, injection technique and needle type).The same day, the patient also received treatment with small amount of botox [botulinum toxin type a] to forehead.On (b)(6) 2021, the patient started to feel distinct rock-hard sausage-shaped lumps (implant site mass) and began to swollen/ swelling/edema/fluid (implant site oedema) due to an allergic reaction (implant site hypersensitivity).From (b)(6) 2021 to (b)(6) 2021, the patient could not remember event course details but swelling and tenderness/pain/sore (implant site pain) started to progress slowly.On (b)(6) 2021, the patient's left cheekbone had become twice the size.There was proper swelling and whole face was very tender.A video chat with initial treating nurse was conducted.The left lump, which was the largest, had migrated and was now located close to the eye.On (b)(6) 2021, the patient met with treating nurse and received the first dose of cortisone [cortisone], 8 tablets, at 4.30 p.M.Thereafter, she was very swollen and tender, and she could not touch the face without having pain in all muscles.Then she developed an edema in the form of a fluid-filled bag under the eye unclear which side the bag was located on at that point.She was still swollen and sore later in the evening but noticed a very small difference.On (b)(6) 2021 in the morning, the patient took 6 cortisone tablets.The swelling had become little smaller and little less painful.The lumps were still the same, equally hard and large.The patient was still swollen under the eye.She had a strange feeling, like a tingling sensation (paraesthesia) in the scalp and head.The patient had described it like when a numb arm wakes up but not as strong.She had no fever, redness or direct heat on the cheek but she felt a little under the weather/frozen and a little dull.She could not do anything physically demanding.On (b)(6) 2021, the patient took 3 cortisone tablets.She was less swollen, the bag under the eye was smaller but the lumps were still the same.She experienced a little more pain in the face again on the right side.On this side, the lump had also moved slightly upwards.She also had more swelling on the lower part of the left side of the face.She had a headache (headache) and was tired which also could have been due to dehydration and poor sleep.After taking the paracetamol [paracetamol], she felt stronger and more alert and even thought about going for a slow paced run the next day.Late in the evening, she started massaging the lumps quite hard and intensely.On (b)(6) 2021, the patient woke up more swollen than ever probably due to the lump massage last evening.Now there was edema also in the left corner of the eye.She got a new round of cortisone prescribed by physician and took 5 tablets in the afternoon.The patient visited her general practitioner, who did an infection test which turned out to be negative.In the evening, she felt like the nose was numb (implant site hypoaesthesia), a bit like having poor blood supply (poor peripheral circulation).On (b)(6) 2021, the patient took 5 cortisone tablets.The swelling had subsided but not as much as last time.The edema was slightly smaller in the morning but increased during the day.She felt rigid in the face when she woke up and could not move the muscles.This subsided later.The nose was no longer numb.The patient visited the clinic for ultrasound and consultation.On (b)(6) 2021, the patient took 5 cortisone tablets.She was still swollen and tender, but better.On (b)(6) 2021, the patient took 5 cortisone tablets.She visited the clinic to dissolve the fillers with hyalase [hyaluronidase] and took another 6 tablets of cortisone after treatment in the afternoon.She was not very swollen with regard to treatment, perhaps due to high dose cortisone.The left lump was approximately half as large in the evening and right lump was almost gone.On (b)(6) 2021, the patient took 2 cortisone tablets in the afternoon.She was not very swollen but there was still sore on the left side.The right side, where the smaller lump had been located, felt strange when she touched it like touching a nerve that had got a bit irritated (maybe by the treatment).On (b)(6) 221, the patient took 1 cortisone tablet in the morning and 2 in the afternoon.Otherwise, the day was like the previous day.She started treatment with kavepenin [phenoxymethylpenicillin potassium].On (b)(6) 2021, the treatment with cortisone was stopped.She felt like the penicillin had some effect.The left lump was a little smaller and the uncomfortable feeling/tightness (injection site discomfort) in the cheek had subsided a bit.On (b)(6) -2021, the status of the patient was as before, but now there was also fluid under the right eye.The patient went to another clinic for injection of more dissolving enzyme.The patient had increasingly felt as if the left lump under the eye had almost grown into the eye bone, sitting very hard against the bone and also around the eye bone she felt like the lump was the largest.Otherwise, the lump had decreased quite a lot.She also felt a tightness in her face, such as reduced mobility.The patient had returned once to the clinic who performed the second hyalase treatment for further hyalase treatment on the left side of her nose because she felt an unpleasant tingling sensation there and suspected that the restylane had migrated (device dislocation) there.The patient reported that the filler intended for the middle face in fact ended up in the nasolabial folds for an unknown reason.She also visited the initial treating nurse a couple of times to dissolve restylane that had migrated to under the right eye and seemed to be the cause of the swelling there.She also had residues of restylane in the cheekbones dissolved.The patient had further stated that the swelling under the right eye never disappeared.For a few months, she regularly (maybe once a month) experienced a bruise (implant site bruising) on the cheek.In connection with this, the swelling decreased slightly.When the bruise disappeared, after about a week, the swelling returned.In the recent months, the swelling had become worse and more widespread.She had recurrent outbreaks of really swollen lumps under the right eye.According to patient, she got less and less muscle control on the right side, where she seems to have suffered a nerve damage (nerve injury) after the intensive massage of restylane lumps in connection with the hyalase dissolution.In (b)(6) 2021, the patient suddenly could not use the muscles.She started using nuface [tretinoin] treatment that stimulates something using microcurrent.She received a little better contact with the muscles but she felt that the face was hanging on the right side (facial paralysis).In 2022, the patient had visited two different injecting nurses.In addition, she revisited the clinic who performed the first dissolution.The therapists had concluded that the patient has restylane left under the right eye which was probably pressing on the lymph and that possibly a biofilm (implant site infection) has been developed.They also concluded that patient had very hollow under the eyes (cutaneous contour deformity).The patient also stated that she had very distinct nasolabial folds after dissolving the lumps.Outcome at the time of the report: rock-hard sausage-shaped lumps was recovered/resolved with sequelae.Swollen/swelling/edema/fluid was not recovered/not resolved/ongoing.Allergic reaction was recovered/resolved.Tenderness/pain/sore was unknown.Strange feeling, like a tingling sensation was unknown.Headache was unknown.Numb was recovered/resolved.Uncomfortable feeling/tightness was recovering/resolving.Restylane had migrated was unknown.Bruise was recovered/resolved.Poor blood supply was unknown.Nerve damage was not recovered/not resolved/ongoing.Biofilm was unknown.Face was hanging on the right side was unknown.Very hollow under the eyes was unknown.Tracking list: v.0 initial, v.1 follow-up attempts have been performed without success.Version opened in order to submit a final mir.
|
| |
|
Manufacturer Narrative
|
|
Company comment: the serious events of mass and oedema at implant site, and the non-serious events of hypersensitivity, pain, hypoaesthesia, bruising and infection at implant site, discomfort at injection site, device dislocation, nerve injury, facial paralysis, cutaneous contour deformity, paraesthesia, headache and poor peripheral circulation were considered expected and possibly related to the treatment.Seriousness criteria include the need for multiple medical interventions to prevent the permanent damage.The potential root cause include treatment procedure.Potential contributory factor include injection technique.The events of hypoaesthesia at implant site and paraesthesia could be secondary to nerve injury due to dislocation of product and facial paralysis due to mass and oedema at implant site.Alternative root cause for the events paraesthesia, headache and facial paralysis include concomitant toxin treatment.The case meets the criteria for expedited reporting to the regulatory authorities.Product notes: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Section g7 cont'd: facial paralysis; cutaneous contour deformity.
|
| |
|
Event Description
|
|
Case reference number (b)(4)is a spontaneous report sent on 13-may-2022 by a female patient (unknown age) reporting her own case.Additional information was received on 17-may-2022 from the patient herself.No information about history of allergies has been provided.The patient had previously received treatment with 1ml restylane volyme and 1 ml juvederm voluma with lidocaine to cheekbones.After this treatment, she experienced a blue and smaller lump under the left eye that disappeared after about two months (case (b)(4)).On (b)(6) 2021, the patient received treatment with approximately 2 ml restylane, 0.8 ml to each side of the cheekbones and 0.2 ml to each side of the middle face (unknown lot number, injection technique and needle type).The same day, the patient also received treatment with small amount of botox [botulinum toxin type a] to forehead.On (b)(6) 2021, the patient started to feel distinct rock-hard sausage-shaped lumps (implant site mass) and began to swollen/ swelling/edema/fluid (implant site oedema) due to an allergic reaction (implant site hypersensitivity).From (b)(6) 2021 to (b)(6) 2021, the patient could not remember event course details but swelling and tenderness/pain/sore (implant site pain) started to progress slowly.On (b)(6) 2021, the patient's left cheekbone had become twice the size.There was proper swelling and whole face was very tender.A video chat with initial treating nurse was conducted.The left lump, which was the largest, had migrated and was now located close to the eye.On (b)(6) 2021, the patient met with treating nurse and received the first dose of cortisone [cortisone], 8 tablets, at 4.30 p.M.Thereafter, she was very swollen and tender, and she could not touch the face without having pain in all muscles.Then she developed an edema in the form of a fluid-filled bag under the eye unclear which side the bag was located on at that point.She was still swollen and sore later in the evening but noticed a very small difference.On (b)(6) 2021 in the morning, the patient took 6 cortisone tablets.The swelling had become little smaller and little less painful.The lumps were still the same, equally hard and large.The patient was still swollen under the eye.She had a strange feeling, like a tingling sensation (paraesthesia) in the scalp and head.The patient had described it like when a numb arm wakes up but not as strong.She had no fever, redness or direct heat on the cheek but she felt a little under the weather/frozen and a little dull.She could not do anything physically demanding.On (b)(6) 2021, the patient took 3 cortisone tablets.She was less swollen, the bag under the eye was smaller but the lumps were still the same.She experienced a little more pain in the face again on the right side.On this side, the lump had also moved slightly upwards.She also had more swelling on the lower part of the left side of the face.She had a headache (headache) and was tired which also could have been due to dehydration and poor sleep.After taking the paracetamol [paracetamol], she felt stronger and more alert and even thought about going for a slow paced run the next day.Late in the evening, she started massaging the lumps quite hard and intensely.On (b)(6) 2021, the patient woke up more swollen than ever probably due to the lump massage last evening.Now there was edema also in the left corner of the eye.She got a new round of cortisone prescribed by physician and took 5 tablets in the afternoon.The patient visited her general practitioner, who did an infection test which turned out to be negative.In the evening, she felt like the nose was numb (implant site hypoaesthesia), a bit like having poor blood supply (poor peripheral circulation).On (b)(6) 2021, the patient took 5 cortisone tablets.The swelling had subsided but not as much as last time.The edema was slightly smaller in the morning but increased during the day.She felt rigid in the face when she woke up and could not move the muscles.This subsided later.The nose was no longer numb.The patient visited the clinic for ultrasound and consultation.On (b)(6) 2021, the patient took 5 cortisone tablets.She was still swollen and tender, but better.On (b)(6) 2021, the patient took 5 cortisone tablets.She visited the clinic to dissolve the fillers with hyalase [hyaluronidase] and took another 6 tablets of cortisone after treatment in the afternoon.She was not very swollen with regard to treatment, perhaps due to high dose cortisone.The left lump was approximately half as large in the evening and right lump was almost gone.On (b)(6) 2021, the patient took 2 cortisone tablets in the afternoon.She was not very swollen but there was still sore on the left side.The right side, where the smaller lump had been located, felt strange when she touched it like touching a nerve that had got a bit irritated (maybe by the treatment).On (b)(6) 221, the patient took 1 cortisone tablet in the morning and 2 in the afternoon.Otherwise, the day was like the previous day.She started treatment with kavepenin [phenoxymethylpenicillin potassium].On (b)(6) 2021, the treatment with cortisone was stopped.She felt like the penicillin had some effect.The left lump was a little smaller and the uncomfortable feeling/tightness (injection site discomfort) in the cheek had subsided a bit.On (b)(6) 2021, the status of the patient was as before, but now there was also fluid under the right eye.The patient went to another clinic for injection of more dissolving enzyme.The patient had increasingly felt as if the left lump under the eye had almost grown into the eye bone, sitting very hard against the bone and also around the eye bone she felt like the lump was the largest.Otherwise, the lump had decreased quite a lot.She also felt a tightness in her face, such as reduced mobility.The patient had returned once to the clinic who performed the second hyalase treatment for further hyalase treatment on the left side of her nose because she felt an unpleasant tingling sensation there and suspected that the restylane had migrated (device dislocation) there.The patient reported that the filler intended for the middle face in fact ended up in the nasolabial folds for an unknown reason.She also visited the initial treating nurse a couple of times to dissolve restylane that had migrated to under the right eye and seemed to be the cause of the swelling there.She also had residues of restylane in the cheekbones dissolved.The patient had further stated that the swelling under the right eye never disappeared.For a few months, she regularly (maybe once a month) experienced a bruise (implant site bruising) on the cheek.In connection with this, the swelling decreased slightly.When the bruise disappeared, after about a week, the swelling returned.In the recent months, the swelling had become worse and more widespread.She had recurrent outbreaks of really swollen lumps under the right eye.According to patient, she got less and less muscle control on the right side, where she seems to have suffered a nerve damage (nerve injury) after the intensive massage of restylane lumps in connection with the hyalase dissolution.In (b)(6) 2021, the patient suddenly could not use the muscles.She started using nuface [tretinoin] treatment that stimulates something using microcurrent.She received a little better contact with the muscles but she felt that the face was hanging on the right side (facial paralysis).In 2022, the patient had visited two different injecting nurses.In addition, she revisited the clinic who performed the first dissolution.The therapists had concluded that the patient has restylane left under the right eye which was probably pressing on the lymph and that possibly a biofilm (implant site infection) has been developed.They also concluded that patient had very hollow under the eyes (cutaneous contour deformity).The patient also stated that she had very distinct nasolabial folds after dissolving the lumps.According to patient, she had received 5-6 hyalase treatment in total at three different clinics but she does not remember any volumes of hyalase used.The swelling/bag under the right eye had decreased and was smaller but still comes and goes.The nerve damage on the right cheek had recovered a little bit as well.However, she stated that her mental health was not good and was mostly connected to the nasolabial folds that have become much more distinct due to all this, and that looks like she has aged 10 years during the recent year.The patent confirmed that she had not received any corrective treatment recently.Outcome at the time of the report: rock-hard sausage-shaped lumps was recovered/resolved with sequelae.Swollen/swelling/edema/fluid was recovering/resolving.Allergic reaction was recovered/resolved.Tenderness/pain/sore was unknown.Strange feeling, like a tingling sensation was unknown.Headache was unknown.Numb was recovered/resolved.Uncomfortable feeling/tightness was recovering/resolving.Restylane had migrated was unknown.Bruise was recovered/resolved.Poor blood supply was unknown.Nerve damage was recovering/resolving.Biofilm was unknown.Face was hanging on the right side was unknown.Very hollow under the eyes was unknown.Tracking list: v.0 initial, v.1 follow-up attempts have been performed without success.Version opened in order to submit a final mir.V.2 fu2 information received on 27-jun-2022 from patient herself.Outcome of the events (implant site oedema and nerve injury) updated.Information about hyalase treatment provided.
|
| |
|
Manufacturer Narrative
|
|
Company comment: the serious events of mass and oedema at implant site, and the non-serious events of hypersensitivity, pain, hypoaesthesia, bruising and infection at implant site, discomfort at injection site, device dislocation, nerve injury, facial paralysis, cutaneous contour deformity, paraesthesia, headache and poor peripheral circulation were considered expected and possibly related to the treatment.Seriousness criteria include the need for multiple medical interventions to prevent the permanent damage.The potential root cause include treatment procedure.Potential contributory factor include injection technique.The events of hypoaesthesia at implant site and paraesthesia could be secondary to nerve injury due to dislocation of product and facial paralysis due to mass and oedema at implant site.Alternative root cause for the events paraesthesia, headache and facial paralysis include concomitant toxin treatment.The case meets the criteria for expedited reporting to the regulatory authorities.Product notes: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Section g7 cont'd: facial paralysis; cutaneous contour deformity.
|
| |
|
Event Description
|
|
Case reference number (b)(4) is a spontaneous report sent on 13-may-2022 by a female patient (unknown age) reporting her own case.Additional information was received on 17-may-2022 from the patient herself.No information about history of allergies has been provided.The patient had previously received treatment with 1ml restylane volyme and 1 ml juvederm voluma with lidocaine to cheekbones in (b)(6) 2019.After this treatment, she experienced a blue and smaller lump under the left eye that disappeared after about two months (case (b)(4)).On (b)(6) 2021, the patient received treatment with approximately 2 ml restylane, 0.8 ml to each side of the cheekbones and 0.2 ml to each side of the middle face (unknown lot number, injection technique and needle type).The same day, the patient also received treatment with small amount of botox [botulinum toxin type a] to forehead.On (b)(6) 2021, the patient started to feel distinct rock-hard sausage-shaped lumps (implant site mass) and began to swollen/ swelling/edema/fluid (implant site oedema) due to an allergic reaction (implant site hypersensitivity).From (b)(6) 2021 to (b)(6) 2021, the patient could not remember event course details but swelling and tenderness/pain/sore (implant site pain) started to progress slowly.On (b)(6) 2021, the patient's left cheekbone had become twice the size.There was proper swelling and whole face was very tender.A video chat with initial treating nurse was conducted.The left lump, which was the largest, had migrated and was now located close to the eye.On (b)(6) 2021, the patient met with treating nurse and received the first dose of cortisone [cortisone], 8 tablets, at 4.30 p.M.Thereafter, she was very swollen and tender, and she could not touch the face without having pain in all muscles.Then she developed an edema in the form of a fluid-filled bag under the eye unclear which side the bag was located on at that point.She was still swollen and sore later in the evening but noticed a very small difference.On (b)(6) 2021 in the morning, the patient took 6 cortisone tablets.The swelling had become little smaller and little less painful.The lumps were still the same, equally hard and large.The patient was still swollen under the eye.She had a strange feeling, like a tingling sensation (paraesthesia) in the scalp and head.The patient had described it like when a numb arm wakes up but not as strong.She had no fever, redness or direct heat on the cheek but she felt a little under the weather/frozen and a little dull.She could not do anything physically demanding.On (b)(6) 2021, the patient took 3 cortisone tablets.She was less swollen, the bag under the eye was smaller but the lumps were still the same.She experienced a little more pain in the face again on the right side.On this side, the lump had also moved slightly upwards.She also had more swelling on the lower part of the left side of the face.She had intense headache (headache) and tired which also could have been due to dehydration and poor sleep.After taking the paracetamol [paracetamol], she felt stronger and more alert and even thought about going for a slow paced run the next day.Late in the evening, she started massaging the lumps quite hard and intensely.On (b)(6) 2021, the patient woke up more swollen than ever probably due to the lump massage last evening.Now there was edema also in the left corner of the eye.She got a new round of cortisone prescribed by physician and took 5 tablets in the afternoon.The patient visited her general practitioner, who did an infection test which turned out to be negative.In the evening, she felt like the nose was numb (implant site hypoaesthesia), a bit like having poor blood supply (poor peripheral circulation).On (b)(6) 2021, the patient took 5 cortisone tablets.The swelling had subsided but not as much as last time.The edema was slightly smaller in the morning but increased during the day.She felt rigid in the face when she woke up and could not move the muscles.This subsided later.The nose was no longer numb.The patient visited the clinic for ultrasound and consultation.On (b)(6) 2021, the patient took 5 cortisone tablets.She was still swollen and tender, but better.On (b)(6) 2021, the patient took 5 cortisone tablets.She visited the clinic to dissolve the fillers with hyalase [hyaluronidase] and took another 6 tablets of cortisone after treatment in the afternoon.She was not very swollen with regard to treatment, perhaps due to high dose cortisone.The left lump was approximately half as large in the evening and right lump was almost gone.On (b)(6) 2021, the patient took 2 cortisone tablets in the afternoon.She was not very swollen but there was still sore on the left side.The right side, where the smaller lump had been located, felt strange when she touched it like touching a nerve that had got a bit irritated (maybe by the treatment).On (b)(6) 2021, the patient took 1 cortisone tablet in the morning and 2 in the afternoon.Otherwise, the day was like the previous day.She started treatment with kavepenin [phenoxymethylpenicillin potassium].On (b)(6) 2021, the treatment with cortisone was stopped.She felt like the penicillin had some effect.The left lump was a little smaller and the uncomfortable feeling/tightness (injection site discomfort) in the cheek had subsided a bit.On (b)(6) 2021, the status of the patient was as before, but now there was also fluid under the right eye.The patient went to another clinic for injection of more dissolving enzyme.The patient had increasingly felt as if the left lump under the eye had almost grown into the eye bone, sitting very hard against the bone and also around the eye bone she felt like the lump was the largest.Otherwise, the lump had decreased quite a lot.She also felt a tightness in her face, such as reduced mobility.The patient had returned once to the clinic who performed the second hyalase treatment for further hyalase treatment on the left side of her nose because she felt an unpleasant tingling sensation there and suspected that the restylane had migrated (device dislocation) there.The patient reported that the filler intended for the middle face in fact ended up in the nasolabial folds for an unknown reason.She also visited the initial treating nurse a couple of times to dissolve restylane that had migrated to under the right eye and seemed to be the cause of the swelling there.She also had residues of restylane in the cheekbones dissolved.The patient had further stated that the swelling under the right eye never disappeared.For a few months, she regularly (maybe once a month) experienced a bruise (implant site bruising) on the cheek.In connection with this, the swelling decreased slightly.When the bruise disappeared, after about a week, the swelling returned.In the recent months, the swelling had become worse and more widespread.She had recurrent outbreaks of really swollen lumps under the right eye.According to patient, she got less and less muscle control on the right side, where she seems to have suffered a nerve damage (nerve injury) after the intensive massage of restylane lumps in connection with the hyalase dissolution.In (b)(6) 2021, the patient suddenly could not use the muscles.She started using nuface [tretinoin] treatment that stimulates something using microcurrent.She received a little better contact with the muscles but she felt that the face was hanging on the right side (facial paralysis).In 2022, the patient had visited two different injecting nurses.In addition, she revisited the clinic who performed the first dissolution.The therapists had concluded that the patient has restylane left under the right eye which was probably pressing on the lymph and that possibly a biofilm (implant site infection) has been developed.They also concluded that patient had very hollow under the eyes (cutaneous contour deformity).The patient also stated that she had very distinct nasolabial folds after dissolving the lumps.According to patient, she had received 5-6 hyalase treatment in total at three different clinics but she does not remember any volumes of hyalase used.The swelling/bag under the right eye had decreased and was smaller but still comes and goes.The nerve damage on the right cheek had recovered a little bit as well.However, she stated that her mental health was not good and was mostly connected to the nasolabial folds that have become much more distinct due to all this, and that looks like she has aged 10 years during the recent year.The patent confirmed that she had not received any corrective treatment recently.The initial treating nurse could not provide her assessment whether patient had facial paralysis or facial asymmetry on the right side and possible nerve damage on the right cheek.The nurse could see that the hard lumps had formed after the restylane treatment and therefore she sent the patient to a physician who had to perform hyalase treatment.After that, the nurse had also treated the patient with hyalase once as well.She could not see that the cheek was hanging or asymmetrical at the time of hyalase treatment.The reporter does not know how many times patient received hyalase treatment, but she thought 3 or 4 treatments.According to the nurse, there was no causal relationship between the events and the botox treatment which was injected in the glabella that time.On 28-jul-2022, additional information was reported from the nurse.The nurse had mentioned on (b)(6) 2022 that she had bought the restylane product from nordic medical solutions, which is a parallel importer.On 19-aug-2022, additional information was received from the patient.The patient mentioned that she had started to experience an intense headache but does not know if it was originating from the complications.The patient still had a swelling which was recurring.Outcome at the time of the report: rock-hard sausage-shaped lumps was recovered/resolved with sequelae.Swollen/swelling/edema/fluid was not recovered/not resolved/ongoing.Allergic reaction was recovered/resolved.Tenderness/pain/sore was unknown.Strange feeling, like a tingling sensation was unknown.Intense headache was not recovered/not resolved/ongoing.Numb was recovered/resolved.Uncomfortable feeling/tightness was recovering/resolving.Restylane had migrated was unknown.Bruise was recovered/resolved.Poor blood supply was unknown.Nerve damage was recovering/resolving.Biofilm was unknown.Face was hanging on the right side was unknown.Very hollow under the eyes was unknown.Tracking list: v.0 initial, v.1 follow-up attempts have been performed without success.Version opened in order to submit a final mir.V.2 fu received on 27-jun-2022 from patient herself.Outcome of the events (implant site oedema and nerve injury) updated.Information about hyalase treatment provided.V.3 fu received on 25-jul-2022 from nurse.Case was medically confirmed.Nurse's assessment of facial paralysis or facial asymmetry on the right side and possible nerve damage, casual relationship between the events and botox and hyalase treatment were provided.V.4 fu received on 19-aug-2022 from patient herself: verbatim of event headache and outcome of events headache and swelling were updated.
|
| |
|
Manufacturer Narrative
|
|
Company comment: the serious events of mass and oedema at implant site, and the non-serious events of hypersensitivity, pain, hypoaesthesia, bruising and infection at implant site, discomfort at injection site, device dislocation, nerve injury, facial paralysis, cutaneous contour deformity, paraesthesia, headache and poor peripheral circulation were considered expected and possibly related to the treatment.Seriousness criteria include the need for multiple medical interventions to prevent the permanent damage.The potential root cause include treatment procedure.Potential contributory factor include injection technique.The events of hypoaesthesia at implant site and paraesthesia could be secondary to nerve injury due to dislocation of product and facial paralysis due to mass and oedema at implant site.Alternative root cause for the events paraesthesia, headache and facial paralysis include concomitant toxin treatment.The case meets the criteria for expedited reporting to the regulatory authorities.Product notes: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Section g7 cont'd: facial paralysis; cutaneous contour deformity.
|
| |
|
Event Description
|
|
Case reference number (b)(6) is a spontaneous report sent on 13-may-2022 by a female patient (unknown age) reporting her own case.Additional information was received on 17-may-2022 from the patient herself.No information about history of allergies has been provided.The patient had previously received treatment with 1ml restylane volyme and 1 ml juvederm voluma with lidocaine to cheekbones.After this treatment, she experienced a blue and smaller lump under the left eye that disappeared after about two months (b)(6).On (b)(6) 2021, the patient received treatment with approximately 2 ml restylane, 0.8 ml to each side of the cheekbones and 0.2 ml to each side of the middle face (unknown lot number, injection technique and needle type).The same day, the patient also received treatment with small amount of botox [botulinum toxin type a] to forehead.On (b)(6) 2021, the patient started to feel distinct rock-hard sausage-shaped lumps (implant site mass) and began to swollen/ swelling/edema/fluid (implant site oedema) due to an allergic reaction (implant site hypersensitivity).From (b)(6) 2021, the patient could not remember event course details but swelling and tenderness/pain/sore (implant site pain) started to progress slowly.On (b)(6) 2021, the patient's left cheekbone had become twice the size.There was proper swelling and whole face was very tender.A video chat with initial treating nurse was conducted.The left lump, which was the largest, had migrated and was now located close to the eye.On (b)(6) 2021, the patient met with treating nurse and received the first dose of cortisone [cortisone], 8 tablets, at 4.30 p.M.Thereafter, she was very swollen and tender, and she could not touch the face without having pain in all muscles.Then she developed an edema in the form of a fluid-filled bag under the eye unclear which side the bag was located on at that point.She was still swollen and sore later in the evening but noticed a very small difference.On (b)(6) 2021 in the morning, the patient took 6 cortisone tablets.The swelling had become little smaller and little less painful.The lumps were still the same, equally hard and large.The patient was still swollen under the eye.She had a strange feeling, like a tingling sensation (paraesthesia) in the scalp and head.The patient had described it like when a numb arm wakes up but not as strong.She had no fever, redness or direct heat on the cheek but she felt a little under the weather/frozen and a little dull.She could not do anything physically demanding.On (b)(6) 2021, the patient took 3 cortisone tablets.She was less swollen, the bag under the eye was smaller but the lumps were still the same.She experienced a little more pain in the face again on the right side.On this side, the lump had also moved slightly upwards.She also had more swelling on the lower part of the left side of the face.She had a headache (headache) and was tired which also could have been due to dehydration and poor sleep.After taking the paracetamol [paracetamol], she felt stronger and more alert and even thought about going for a slow paced run the next day.Late in the evening, she started massaging the lumps quite hard and intensely.On (b)(6) 2021, the patient woke up more swollen than ever probably due to the lump massage last evening.Now there was edema also in the left corner of the eye.She got a new round of cortisone prescribed by physician and took 5 tablets in the afternoon.The patient visited her general practitioner, who did an infection test which turned out to be negative.In the evening, she felt like the nose was numb (implant site hypoaesthesia), a bit like having poor blood supply (poor peripheral circulation).On (b)(6) 2021, the patient took 5 cortisone tablets.The swelling had subsided but not as much as last time.The edema was slightly smaller in the morning but increased during the day.She felt rigid in the face when she woke up and could not move the muscles.This subsided later.The nose was no longer numb.The patient visited the clinic for ultrasound and consultation.On (b)(6) 2021, the patient took 5 cortisone tablets.She was still swollen and tender, but better.On (b)(6) 2021, the patient took 5 cortisone tablets.She visited the clinic to dissolve the fillers with hyalase [hyaluronidase] and took another 6 tablets of cortisone after treatment in the afternoon.She was not very swollen with regard to treatment, perhaps due to high dose cortisone.The left lump was approximately half as large in the evening and right lump was almost gone.On (b)(6) 2021, the patient took 2 cortisone tablets in the afternoon.She was not very swollen but there was still sore on the left side.The right side, where the smaller lump had been located, felt strange when she touched it like touching a nerve that had got a bit irritated (maybe by the treatment).On (b)(6) 221, the patient took 1 cortisone tablet in the morning and 2 in the afternoon.Otherwise, the day was like the previous day.She started treatment with kavepenin [phenoxymethylpenicillin potassium].On (b)(6) 2021, the treatment with cortisone was stopped.She felt like the penicillin had some effect.The left lump was a little smaller and the uncomfortable feeling/tightness (injection site discomfort) in the cheek had subsided a bit.On 27-apr- 2021, the status of the patient was as before, but now there was also fluid under the right eye.The patient went to another clinic for injection of more dissolving enzyme.The patient had increasingly felt as if the left lump under the eye had almost grown into the eye bone, sitting very hard against the bone and also around the eye bone she felt like the lump was the largest.Otherwise, the lump had decreased quite a lot.She also felt a tightness in her face, such as reduced mobility.The patient had returned once to the clinic who performed the second hyalase treatment for further hyalase treatment on the left side of her nose because she felt an unpleasant tingling sensation there and suspected that the restylane had migrated (device dislocation) there.The patient reported that the filler intended for the middle face in fact ended up in the nasolabial folds for an unknown reason.She also visited the initial treating nurse a couple of times to dissolve restylane that had migrated to under the right eye and seemed to be the cause of the swelling there.She also had residues of restylane in the cheekbones dissolved.The patient had further stated that the swelling under the right eye never disappeared.For a few months, she regularly (maybe once a month) experienced a bruise (implant site bruising) on the cheek.In connection with this, the swelling decreased slightly.When the bruise disappeared, after about a week, the swelling returned.In the recent months, the swelling had become worse and more widespread.She had recurrent outbreaks of really swollen lumps under the right eye.According to patient, she got less and less muscle control on the right side, where she seems to have suffered a nerve damage (nerve injury) after the intensive massage of restylane lumps in connection with the hyalase dissolution.In (b)(6) 2021, the patient suddenly could not use the muscles.She started using nuface [tretinoin] treatment that stimulates something using microcurrent.She received a little better contact with the muscles but she felt that the face was hanging on the right side (facial paralysis).In 2022, the patient had visited two different injecting nurses.In addition, she revisited the clinic who performed the first dissolution.The therapists had concluded that the patient has restylane left under the right eye which was probably pressing on the lymph and that possibly a biofilm (implant site infection) has been developed.They also concluded that patient had very hollow under the eyes (cutaneous contour deformity).The patient also stated that she had very distinct nasolabial folds after dissolving the lumps.According to patient, she had received 5-6 hyalase treatment in total at three different clinics but she does not remember any volumes of hyalase used.The swelling/bag under the right eye had decreased and was smaller but still comes and goes.The nerve damage on the right cheek had recovered a little bit as well.However, she stated that her mental health was not good and was mostly connected to the nasolabial folds that have become much more distinct due to all this, and that looks like she has aged 10 years during the recent year.The patent confirmed that she had not received any corrective treatment recently.The initial treating nurse could not provide her assessment whether patient had facial paralysis or facial asymmetry on the right side and possible nerve damage on the right cheek.The nurse could see that the hard lumps had formed after the restylane treatment and therefore she sent the patient to a physician who had to perform hyalase treatment.After that, the nurse had also treated the patient with hyalase once as well.She could not see that the cheek was hanging or asymmetrical at the time of hyalase treatment.The reporter does not know how many times patient received hyalase treatment, but she thought 3 or 4 treatments.According to the nurse, there was no causal relationship between the events and the botox treatment which was injected in the glabella that time.On 28-jul-2022 additional information was reported from the nurse.The nurse had mentioned on 25-jul-2022 that she had bought the restylane product from nordic medical solutions, which is a parallel importer.Outcome at the time of the report: rock-hard sausage-shaped lumps was recovered/resolved with sequelae.Swollen/swelling/edema/fluid was recovering/resolving.Allergic reaction was recovered/resolved.Tenderness/pain/sore was unknown.Strange feeling, like a tingling sensation was unknown.Headache was unknown.Numb was recovered/resolved.Uncomfortable feeling/tightness was recovering/resolving.Restylane had migrated was unknown.Bruise was recovered/resolved.Poor blood supply was unknown.Nerve damage was recovering/resolving.Biofilm was unknown.Face was hanging on the right side was unknown.Very hollow under the eyes was unknown.Tracking list: v.0 initial, v.1 follow-up attempts have been performed without success.Version opened in order to submit a final mir.V.2 fu received on 27-jun-2022 from patient herself.Outcome of the events (implant site oedema and nerve injury) updated.Information about hyalase treatment provided.V.3 fu received on 25-jul-2022 from nurse.Case was medically confirmed.Nurse's assessment of facial paralysis or facial asymmetry on the right side and possible nerve damage, casual relationship between the events and botox and hyalase treatment were provided.
|
| |
|
Manufacturer Narrative
|
|
Company comment: the serious events of mass and oedema at implant site, and the non-serious events of hypersensitivity, pain, hypoaesthesia, bruising and infection at implant site, discomfort at injection site, device dislocation, nerve injury, facial paralysis, cutaneous contour deformity, paraesthesia, headache and poor peripheral circulation were considered expected and possibly related to the treatment.Seriousness criteria include the need for multiple medical interventions to prevent the permanent damage.The potential root cause include treatment procedure.Potential contributory factor include injection technique.The events of hypoaesthesia at implant site and paraesthesia could be secondary to nerve injury due to dislocation of product and facial paralysis due to mass and oedema at implant site.Alternative root cause for the events paraesthesia, headache and facial paralysis include concomitant toxin treatment.The case meets the criteria for expedited reporting to the regulatory authorities.Product notes: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Section g7 cont'd: facial paralysis; cutaneous contour deformity.
|
| |
|
Manufacturer Narrative
|
|
Company comment: the serious events of mass and oedema at implant site, and the non-serious events of hypersensitivity, pain, hypoaesthesia, bruising and infection at implant site, discomfort at injection site, device dislocation, nerve injury, facial paralysis, cutaneous contour deformity, paraesthesia, headache and poor peripheral circulation were considered expected and possibly related to the treatment.Seriousness criteria include medical intervention and permanent damage.The potential root cause include treatment procedure.Potential contributory factor include injection technique.Potential contributory factor for device migration includes excessive massage by patient.The events of hypoaesthesia at implant site and paraesthesia could be secondary to nerve injury due to the dislocation of the product, and the event of facial paralysis could be due to the mass and oedema at implant site.Alternative root cause for the events paraesthesia, headache and facial paralysis include concomitant toxin treatment.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.
|
| |
|
Event Description
|
|
Case reference number (b)(4) is a spontaneous report sent on 13-may-2022 by a female patient (unknown age) reporting her own case.Additional information was received on 17-may-2022 from the patient herself.No information about history of allergies has been provided.The patient had previously received treatment with 1 ml restylane volyme and 1 ml juvederm voluma with lidocaine to the cheekbones in aug-2019.After this treatment, she experienced a blue and smaller lump under the left eye that disappeared after about two months (case (b)(4)).On (b)(6) 2021 the patient received treatment with approximately 2 ml restylane, 0.8 ml to each side of the cheekbones and 0.2 ml to each side of the middle face (unknown lot number, injection technique and needle type).The same day, the patient also received treatment with small amount of botox [botulinum toxin type a] to forehead.On (b)(6) 2021 the patient started to feel distinct rock-hard sausage-shaped lumps (implant site mass) and began to swollen/ swelling/edema/fluid (implant site oedema) due to an allergic reaction (implant site hypersensitivity).From (b)(6) 2021 the patient could not remember event course details but swelling and tenderness/pain/sore (implant site pain) started to progress slowly.On (b)(6) 2021 the patient's left cheekbone had become twice the size.There was proper swelling and whole face was very tender.A video chat with initial treating nurse was conducted.The left lump, which was the largest, had migrated and was now located close to the eye.On (b)(6) 2021 the patient met with treating nurse and received the first dose of cortisone [cortisone], 8 tablets, at 4.30 p.M.Thereafter, she was very swollen and tender, and she could not touch the face without having pain in all muscles.Then she developed an edema in the form of a fluid-filled bag under the eye, unclear which side the bag was located on at that point.She was still swollen and sore later in the evening but noticed a very small difference.On (b)(6) 2021 in the morning, the patient took 6 cortisone tablets.The swelling had become little smaller and little less painful.The lumps were still the same, equally hard and large.The patient was still swollen under the eye.She had a strange feeling, like a tingling sensation (paraesthesia) in the scalp and head.The patient had described it like when a numb arm wakes up but not as strong.She had no fever, redness or direct heat on the cheek but she felt a little under the weather/frozen and a little dull.She could not do anything physically demanding.On (b)(6) 2021 the patient took 3 cortisone tablets.She was less swollen, the bag under the eye was smaller but the lumps were still the same.She experienced a little more pain in the face again on the right side.On this side, the lump had also moved slightly upwards.She also had more swelling on the lower part of the left side of the face.She had intense headache (headache) and was tired which also could have been due to dehydration and poor sleep.After taking the paracetamol [paracetamol], she felt stronger and more alert and even thought about going for a slow paced run the next day.Late in the evening, she started massaging the lumps quite hard and intensely.On (b)(6) 2021 the patient woke up more swollen than ever probably due to the lump massage last evening.Now there was edema also in the left corner of the eye.She got a new round of cortisone prescribed by the physician and took 5 tablets in the afternoon.The patient visited her general practitioner, who did an infection test which turned out to be negative.In the evening, she felt like the nose was numb (implant site hypoaesthesia), a bit like having poor blood supply (poor peripheral circulation).On (b)(6) 2021 the patient took 5 cortisone tablets.The swelling had subsided but not as much as last time.The edema was slightly smaller in the morning but increased during the day.She felt rigid in the face when she woke up and could not move the muscles.This subsided later.The nose was no longer numb.The patient visited the clinic for ultrasound and consultation.On (b)(6) 2021 the patient took 5 cortisone tablets.She was still swollen and tender, but better.On (b)(6) 2021 the patient took 5 cortisone tablets.She visited the clinic to dissolve the fillers with hyalase [hyaluronidase] and took another 6 tablets of cortisone after treatment in the afternoon.She was not very swollen with regard to treatment, perhaps due to the high dose of cortisone.The left lump was approximately half as large in the evening and the right lump was almost gone.On (b)(6) 2021 the patient took 2 cortisone tablets in the afternoon.She was not very swollen but there was still sore on the left side.The right side, where the smaller lump had been located, felt strange when she touched it like touching a nerve that had got a bit irritated (maybe by the treatment).On (b)(6) 2021 the patient took 1 cortisone tablet in the morning and 2 in the afternoon.Otherwise, the day was like the previous day.She started treatment with kavepenin [phenoxymethylpenicillin potassium].On (b)(6) 2021 the treatment with cortisone was stopped.She felt like the penicillin had some effect.The left lump was a little smaller and the uncomfortable feeling/tightness (injection site discomfort) in the cheek had subsided a bit.On (b)(6) 2021 the status of the patient was as before, but now there was also fluid under the right eye.The patient went to another clinic for injection of more dissolving enzyme.The patient had increasingly felt as if the left lump under the eye had almost grown into the eye bone, sitting very hard against the bone and also around the eye bone she felt like the lump was the largest.Otherwise, the lump had decreased quite a lot.She also felt a tightness in her face, such as reduced mobility.The patient had returned once to the clinic who performed the second hyalase treatment for further hyalase treatment on the left side of her nose because she felt an unpleasant tingling sensation there and suspected that the restylane had migrated (device dislocation) there.The patient reported that the filler intended for the middle face in fact ended up in the nasolabial folds for an unknown reason.She also visited the initial treating nurse a couple of times to dissolve restylane that had migrated to under the right eye and seemed to be the cause of the swelling there.She also had residues of restylane in the cheekbones dissolved.The patient had further stated that the swelling under the right eye never disappeared.For a few months, she regularly (maybe once a month) experienced a bruise (implant site bruising) on the cheek.In connection with this, the swelling decreased slightly.When the bruise disappeared, after about a week, the swelling returned.In the recent months, the swelling had become worse and more widespread.She had recurrent outbreaks of really swollen lumps under the right eye.According to the patient, she got less and less muscle control on the right side, where she seems to have suffered a nerve damage (nerve injury) after the intensive massage of restylane lumps in connection with the hyalase dissolution.In (b)(6) 2021 the patient suddenly could not use the muscles.She started using nuface [tretinoin] treatment that stimulates something using microcurrent.She received a little better contact with the muscles, but she felt that the face was hanging on the right side (facial paralysis).In 2022, the patient had visited two different injecting nurses.In addition, she revisited the clinic who performed the first dissolution.The therapists had concluded that the patient has restylane left under the right eye which was probably pressing on the lymph and that possibly a biofilm (implant site infection) has developed.They also concluded that the patient had very hollow under the eyes (cutaneous contour deformity).The patient also stated that she had very distinct nasolabial folds after dissolving the lumps.According to patient, she had received 5-6 hyalase treatment in total at three different clinics but she does not remember any volumes of hyalase used.The swelling/bag under the right eye had decreased and was smaller but still comes and goes.The nerve damage on the right cheek had recovered a little bit as well.However, she stated that her mental health was not good and was mostly connected to the nasolabial folds that have become much more distinct due to all this, and that looks like she has aged 10 years during the recent year.The patent confirmed that she had not received any corrective treatment recently.The initial treating nurse could not provide her assessment whether patient had facial paralysis or facial asymmetry on the right side and possible nerve damage on the right cheek.The nurse could see that the hard lumps had formed after the restylane treatment and therefore she sent the patient to a physician who had to perform hyalase treatment.After that, the nurse had also treated the patient with hyalase once as well.She could not see that the cheek was hanging or asymmetrical at the time of the hyalase treatment.The reporter does not know how many times patient received hyalase treatment, but she thought 3 or 4 treatments.According to the nurse, there was no causal relationship between the events and the botox treatment which was injected in the glabella that time.On 28-jul-2022, additional information was reported from the nurse.The nurse had mentioned on (b)(6) 2022 that she had bought the restylane product from nordic medical solutions, which is a parallel importer.On 19-aug-2022, additional information was received from the patient.The patient mentioned that she had started to experience an intense headache but does not know if it was originating from the complications.The patient still had a swelling which was recurring.In 2023 (just over two weeks ago from the latest date of report), the patient suddenly experienced a very strong reaction in the nose, with similar pain and discomfort that she felt just in the beginning.She further explained that it started with pain and discomfort on the nose and currently it had evolved into a significant hard swelling on the bridge of the nose, like a lump/hump.According to patient's own theory, the hcp never managed to remove all the restylane/bacteria on the side of the nose, and it was restylane residues with biofilm that had reacted for some reason.The patient herself thought that she might need additional hyaluronidase and penicillin treatments and these events were connected to the same restylane treatment with following complications, received two years ago.Outcome at the time of the report: rock-hard sausage-shaped lumps was not recovered/not resolved/ongoing.Swollen/swelling/edema/fluid was not recovered/not resolved/ongoing.Allergic reaction was recovered/resolved.Tenderness/pain/sore was not recovered/not resolved/ongoing.Strange feeling, like a tingling sensation was unknown.Intense headache was not recovered/not resolved/ongoing.Numb was recovered/resolved.Uncomfortable feeling/tightness was not recovered/not resolved/ongoing.Restylane had migrated was unknown.Bruise was recovered/resolved.Poor blood supply was unknown.Nerve damage was recovering/resolving.Biofilm was unknown.Face was hanging on the right side was unknown.Very hollow under the eyes was unknown.Tracking list: v.0 initial, v.1 follow-up attempts have been performed without success.Version opened in order to submit a final mir.V.2 fu received on (b)(6) 2022 from the patient: outcome of the events (implant site oedema and nerve injury) updated.Information about hyalase treatment provided.V.3 fu received on (b)(6) 2022 from the nurse: case was medically confirmed.Nurse's assessment of facial paralysis or facial asymmetry on the right side and possible nerve damage, causal relationship between the events and botox and hyalase treatment were provided.V.4 fu received on (b)(6) 2022 from the patient: verbatim of event headache and outcome of events headache and swelling were updated.V.5 fu received on (b)(6) 2023 from the patient: event location, outcome and reporter causality of events (pain, swelling, mass and infection at implant site, and injection site discomfort) were updated.
|
| |
|
Search Alerts/Recalls
|
|
|
