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| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abscess (1690); Hypersensitivity/Allergic reaction (1907); Scarring (2061); Sepsis (2067); Swelling (2091); Skin Inflammation (2443)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Capa: the ifu precaution section includes information that injection procedures are associated with a risk of infection.The company will closely monitor cases of infection that are reported with these products.Preventative action: aseptic technique and standard practice to prevent cross-infections are to be observed.The serious events of abscess and hypersensitivity were considered unexpected and possibly related to the treatment.The serious events of inflammation, swelling and implant site scar were considered expected and possibly related to the treatment.The abscess and hypersensitivity events were considered unexpected due to persistence for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.Potential contributory factors for the events include an inflammatory reaction triggered by interactions with preexisting dermal filler implants.Implants by unauthorized users might also have contributed to the reported events.The adverse event report meets the regulatory criteria for expedited reporting to the regulatory authorities.Pharmacovigilance comments: the serious events of abscess and hypersensitivity were considered unexpected and possibly related to the treatment.The serious events of inflammation, swelling and implant site scar were considered expected and possibly related to the treatment.The abscess and hypersensitivity events were considered unexpected due to persistence for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.Potential contributory factors for the events include an inflammatory reaction triggered by interactions with preexisting dermal filler implants.Implants by unauthorized users might also have contributed to the reported events.The adverse event report meets the regulatory criteria for expedited reporting to the regulatory authorities.It was not reported if the device was available for the manufacturer to assess.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 09-oct-2017 by a nurse which refers to a female aged (b)(6) years.Follow up information received 19-oct-2017 and 24-oct-2017 from the nurse.The patient's medical history included pollen allergy.The patient had previously received treatment with juvederm in (b)(6) 2015.The patient has also received unspecified type of filler in 2011.According to the patient, she has not performed any other treatments in the period between (b)(6) 2016 and until today.On (b)(6) 2016, the patient received treatment with 1 ml restylane defyne (lot unknown) in the cheeks and under the eyes; and 1 ml restylane refyne (lot 14775-1) to the nasolabial folds and the corners of the mouth.The patient came back for a revisit on (b)(6) 2016.At that time, everything looked fine and they did a touch-up with restylane refyne in the nasolabial folds and the lips.In (b)(6) 2016 the patient experienced swelling(implant site swelling)(note: location of the swelling was unclear), which increased in (b)(6) 2016.The patient sought emergency care at the hospital.Culture was performed.No bacteria but she received antibiotics.The swelling came back in (b)(6) 2016.An abscess with pus(implant site abscess) was emptied, and some sort of drainage was put in.After this she experienced the same in the other cheek.It was opened up and checked if it was something coming from the bone, if it could be bacteria that had spread from the teeth.No result, they found nothing.The patient received a lot of antibiotics, but stopped with this when they concluded that it was not caused by bacteria.The swelling decreased.In (b)(6) 2017 she met a physician who referred her for puncture.Did not show cancer cells.Drained out a lot of fluid and the swelling decreased.In (b)(6) 2017 she came back for check-up again, without swelling.The swelling returned in (b)(6) 2017.The cheekbone was opened and drained for possible inflammation(implant site inflammation).Then the problems appeared on the right cheek - an abscess.Also, the incision on the left cheek burst and pus poured out.The patient met with a physician again.They asked if she had taken fillers and asked her to contact the treating nurse (the reporter).According to the nurse, the patient had not contacted her before this, but she contacted the nurse in (b)(6) 2017 after having met a dermatologist.New swelling in the middle of (b)(6) 2017.The nurse met the patient on (b)(6) 2017 and there was no on-going inflammation at that time.On the day of the report, (b)(6) 2017, the patient had a swelling again on the right cheek.On receipt of follow-up 2 on (b)(6) 2017, the case was upgraded to unanticipated status due to the persistence of the events for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.On the day of the initial report ((b)(6) 2017), the patient has two really ugly scar on the cheek (implant site scar) where they opened up.On the other cheek she has a dark spot.No infection.The patient thinks she had some sort of allergic reaction (hypersensitivity) to the treatment.The situation is under control.No infection, no abscesses or similar for quite a while.The reporter thought of injecting hyalase, but has waited with that since she is unsure if the problems are due to the treatment.Outcome at the time of the report: swelling was not recovered/not resolved.Abscess with pus was recovering/resolving.Allergic reaction was recovering/resolving.Possible inflammation was recovering/resolving.Scars on the cheek was not recovered/not resolved.
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Manufacturer Narrative
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(b)(4).Exemption number: e2015005.(b)(4).Capa: the ifu precaution section includes information that injection procedures are associated with a risk of infection.The company will closely monitor cases of infection that are reported with these products.Preventative action: aseptic technique and standard practice to prevent cross-infections are to be observed.The serious events of abscess and hypersensitivity were considered unexpected and possibly related to the treatment.The serious events of inflammation, swelling and implant site scar were considered expected and possibly related to the treatment.The abscess and hypersensitivity events were considered unexpected due to persistence for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.Potential contributory factors for the events include an inflammatory reaction triggered by interactions with preexisting dermal filler implants.Implants by unauthorized users might also have contributed to the reported events.The adverse event report meets the regulatory criteria for expedited reporting to the regulatory authorities.Pharmacovigilance comments: the serious events of abscess and hypersensitivity were considered unexpected and possibly related to the treatment.The serious events of inflammation, swelling and implant site scar were considered expected and possibly related to the treatment.The abscess and hypersensitivity events were considered unexpected due to persistence for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.Potential contributory factors for the events include an inflammatory reaction triggered by interactions with preexisting dermal filler implants.Implants by unauthorized users might also have contributed to the reported events.The adverse event report meets the regulatory criteria for expedited reporting to the regulatory authorities.Additional comments: it was not reported if the device was available for the manufacturer to assess.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2017 by a nurse which refers to a female aged (b)(6).Follow up information received 19-oct-2017 and 24-oct-2017 from the nurse.The patient's medical history included pollen allergy.The patient had previously received treatment with juvederm in (b)(6) 2015.The patient has also received unspecified type of filler in 2011.According to the patient, she has not performed any other treatments in the period between (b)(6) 2016 and until today.On (b)(6) 2016, the patient received treatment with 1 ml restylane defyne (lot unknown) in the cheeks and under the eyes; and 1 ml restylane refyne (lot 14775-1) to the nasolabial folds and the corners of the mouth.The patient came back for a revisit on (b)(6) 2016.At that time, everything looked fine and they did a touch-up with restylane refyne in the nasolabial folds and the lips.In (b)(6) 2016 the patient experienced swelling (implant site swelling)(note: location of the swelling was unclear), which increased in (b)(6) 2016.The patient sought emergency care at the hospital.Culture was performed.No bacteria but she received antibiotics.The swelling came back in (b)(6) 2016.An abscess with pus (implant site abscess) was emptied, and some sort of drainage was put in.After this she experienced the same in the other cheek.It was opened up and checked if it was something coming from the bone, if it could be bacteria that had spread from the teeth.No result, they found nothing.The patient received a lot of antibiotics, but stopped with this when they concluded that it was not caused by bacteria.The swelling decreased.In (b)(6) 2017 she met a physician who referred her for puncture.Did not show cancer cells.Drained out a lot of fluid and the swelling decreased.In (b)(6) 2017 she came back for check-up again, without swelling.The swelling returned in (b)(6) 2017.The cheekbone was opened and drained for possible inflammation(implant site inflammation).Then the problems appeared on the right cheek - an abscess.Also, the incision on the left cheek burst and pus poured out.The patient met with a physician again.They asked if she had taken fillers and asked her to contact the treating nurse (the reporter).According to the nurse, the patient had not contacted her before this, but she contacted the nurse in (b)(6) 2017 after having met a dermatologist.New swelling in the middle of (b)(6) 2017.The nurse met the patient on (b)(6) 2017 and there was no on-going inflammation at that time.On the day of the report, (b)(6) 2017, the patient had a swelling again on the right cheek.On receipt of follow-up 2 on (b)(6) 2017, the case was upgraded to unanticipated status due to the persistence of the events for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.On the day of the initial report ((b)(6) 2017), the patient has two really ugly scar on the cheek(implant site scar) where they opened up.On the other cheek she has a dark spot.No infection.The patient thinks she had some sort of allergic reaction(hypersensitivity) to the treatment.The situation is under control.No infection, no abscesses or similar for quite a while.The reporter thought of injecting hyalase, but has waited with that since she is unsure if the problems are due to the treatment.Outcome at the time of the report: swelling was not recovered/not resolved.Abscess with pus was recovering/resolving.Allergic reaction was recovering/resolving.Possible inflammation was recovering/resolving.Scars on the cheek was not recovered/not resolved.Tracking list: v.0 initial and fu from 19-oct-2017 and 24-oct-2017.V.1 23-nov-2017: opened to create the final mir.No new information provided by the reporter in the follow-up attempts.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2017 by a nurse which refers to a female aged 62 years.Follow up information received (b)(6) 2017 and (b)(6) 2017 from the nurse, and from the patient on (b)(6) 2018, and 18-apr-2018 from the external medical advisor.The patient's medical history included pollen allergy.The patient had previously received treatment with juvederm in (b)(6) 2015 by a skin therapist that was not authorized, as well as a nurse.The patient does not know in what area she was treated or the name of the product that was used.The patient has also received unspecified type of filler in 2011.According to the patient, she has not performed any other treatments in the period between (b)(6) 2016 and until today.On (b)(6) 2016, the patient received treatment with 1 ml restylane defyne (lot unknown) in the cheeks and under the eyes, injection point at the temple; and 1 ml restylane refyne (lot 14775-1) to the nasolabial folds and the corners of the mouth.The patient came back for a revisit on (b)(6) 2016.At that time, everything looked fine and they did a touch-up with restylane refyne in the nasolabial folds and the lips.In sep-2016 the patient experienced swelling(implant site swelling) in the temple area.The patient thought the cause of it was the zygomatic bone, which she previously had hurt.In november 2016 the swelling increased and spread around the left eye.The patient sought emergency care at the hospital.Drainage of fluid was performed.The culture showed no bacteria but the patient received heracillin.The swelling came back in (b)(6) 2016.An abscess with pus(implant site abscess) was emptied, and some sort of drainage was put in.After this she experienced the same in the other cheek.It was opened up and checked if it was something coming from the bone, if it could be bacteria that had spread from the teeth.No result, they found nothing.The patient received a lot of antibiotics, but stopped with this when they concluded that it was not caused by bacteria.The swelling decreased.In (b)(6) 2017 she met a physician (ent specialist) who referred her for puncture.Did not show cancer cells.Drained out a lot of fluid and the swelling decreased.In mar-2017 she came back for check-up again with the ent specialist.The swelling was gone and the physician did not do anything.The swelling returned in (b)(6) 2017.The cheekbone was opened and drained for possible inflammation(implant site inflammation).Then the problems appeared on the right cheek - an abscess.Also, the incision on the left cheek burst and pus poured out.The patient met with a physician again.The physician asked if she had taken fillers and the patient could connect the problems to the treatment performed in august.The physician asked her to contact the treating nurse (the reporter).According to the nurse, the patient had not contacted her before this, but she contacted the nurse in (b)(6) 2017 after having met a dermatologist.She was prescribed penicillin [penicillin nos] and was then after this swelling visiting an emergency room and sepsis was suspected(sepsis).She was then transferred and in (b)(6) 2017 she visited dermatologist at that prescribed tetracyclines for several weeks.In (b)(6) the swelling came back once more.In (b)(6) 2017 when antibiotic treatment was stopped she experienced a swelling over the cheek and the area was drained and was emptied.After this the left side has not been swollen again but the right side has troubled her in (b)(6) 2017 with an abscess that drained.New swelling in the middle of (b)(6) 2017 in the left cheek and around left eye.The nurse met the patient on (b)(6) 2017 and there was no on-going inflammation at that time.On the day of the report, (b)(6) 2017, the patient had a swelling again on the right cheek.On the day of the initial report (b)(6) 2017), the patient has two really ugly scar on the cheek(implant site scar) where they opened up.On the other cheek she has a dark spot.No infection.The patient thinks she had some sort of allergic reaction(hypersensitivity) to the treatment.The situation is under control.No infection, no abscesses or similar for quite a while.The reporter thought of injecting hyalase, but has waited with that since she is unsure if the problems are due to the treatment.The patient claims that the clinic has "not informed me that injections with hyaluronic acid under the skin can cause adverse reactions for some people, as abscesses, redness in the skin and swelling".Follow up information received on 28-mar-2018 from the patient.The patient stated that: "i have still not recovered.I attach pictures taken yesterday.A few weeks ago, i got an abscess on the right side towards the temple.It is now about to decline.On the left side i have several scars." follow up information received on (b)(6) 2018 from an external medical advisor.Status of today (b)(6) 2018): the patient is not using antibiotics.She is hardened and not tender and has a blue discoloring over the right zygomatic bone area.On left side indented scar areas but no redness in the skin.The medical advisor injected hyalase [hyaluronidase] in the lateral part of the tear throughs and out over the cheek within the scarring areas on both sides, more on the right than on the left.The patient was also prescribed heracillin [flucloxacillin sodium] in case she should react with swelling in the area or signs of infection.On (b)(6) 2018, the patient visited the external medical advisor again.The medical advisor reported that the area had softened significantly and there has been no swelling at the left eye.It is, however, hardened around the right cheek.There was no infection last time and she has not used any antibiotic.Hyalase was injected again in the indurated area of the right cheek.Outcome at the time of the report: swelling was not recovered/not resolved.Abscess with pus was recovering/resolving.Allergic reaction was recovering/resolving.Possible inflammation was recovering/resolving.Scars on the cheek was not recovered/not resolved.Sepsis was suspected was recovered/resolved.Tracking list: v.0 initial and fu from (b)(6) 2017 and (b)(6) 2017.V.1 opened to create the final mir.No new information provided by the reporter in the follow-up attempts.V.2 fu received on (b)(6) 2018 and (b)(6) 2018 by the patient.The patient provided a description of the problems (similar to the description from the reporting nurse) v.3 fu received from the external medical advisor that had met the patient on (b)(6) 2018 and on (b)(6) 2018.Added specification of type of antibiotics, use of hyalase, added event of sepsis, and information from two visits with a physician.
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Manufacturer Narrative
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Q-med ab, manufacturer, registration no.(b)(4).Se17009583 follow-up 3 report.Capa: the ifu precaution section includes information that injection procedures are associated with a risk of infection.Aseptic technique and standard practice to prevent cross-infections are to be observed.The company will closely monitor cases of infection that are reported with these products.Manufacturing narrative: lot number was not reported.Pharmacovigilance comments: the serious events of abscess, suspected sepsis, hypersensitivity and swelling were considered unexpected and possibly related to the treatment.The serious events of inflammation and implant site scar were considered expected and possibly related to the treatment.The abscess, hypersensitivity and swelling events were considered unexpected due to persistence for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.Serious criteria included permanent damage for scarring, and medical intervention to prevent permanent damage for the remaining events.Potential contributory factors for the events include an inflammatory reaction associated with preexisting dermal filler implants.Implants by unauthorized users might also have contributed to the reported events.An association with these events is less substantiated for restylane refyne because it was not implanted in the sites where the events occurred.The adverse event report meets the regulatory criteria for expedited reporting to the regulatory authorities.Additional comments: it was not reported if the device was available for the manufacturer to assess.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 09-oct-2017 by a nurse which refers to a female aged 62 years.Follow up information received 19-oct-2017 and 24-oct-2017 from the nurse, and from the patient on 19-mar-2018.The patient's medical history included pollen allergy.The patient had previously received treatment with juvederm in (b)(6) 2015 by a skin therapist that was not authorized, as well as a nurse.The patient does not know in what area she was treated or the name of the product that was used.The patient has also received unspecified type of filler in 2011.According to the patient, she has not performed any other treatments in the period between (b)(6) 2016 and until today.On (b)(6) 2016, the patient received treatment with 1 ml restylane defyne (lot unknown) in the cheeks and under the eyes, injection point at the temple; and 1 ml restylane refyne (lot 14775-1) to the nasolabial folds and the corners of the mouth.The patient came back for a revisit on (b)(6) 2016.At that time, everything looked fine and they did a touch-up with restylane refyne in the nasolabial folds and the lips.In (b)(6) 2016 the patient experienced swelling(implant site swelling) in the temple area.The patient thought the cause of it was the zygomatic bone, which she previously had hurt.In (b)(6) 2016 the swelling increased and spread around the left eye.The patient sought emergency care at the hospital.Drainage of fluid was performed.The culture showed no bacteria but the patient received antibiotics.The swelling came back in (b)(6) 2016.An abscess with pus(implant site abscess) was emptied, and some sort of drainage was put in.After this she experienced the same in the other cheek.It was opened up and checked if it was something coming from the bone, if it could be bacteria that had spread from the teeth.No result, they found nothing.The patient received a lot of antibiotics, but stopped with this when they concluded that it was not caused by bacteria.The swelling decreased.In (b)(6) 2017 she met a physician (ent specialist) who referred her for puncture.Did not show cancer cells.Drained out a lot of fluid and the swelling decreased.In (b)(6) 2017 she came back for check-up again with the ent specialist.The swelling was gone and the physician did not do anything.The swelling returned in (b)(6) 2017.The cheekbone was opened and drained for possible inflammation(implant site inflammation).Then the problems appeared on the right cheek - an abscess.Also, the incision on the left cheek burst and pus poured out.The patient met with a physician again.The physician asked if she had taken fillers and the patient could connect the problems to the treatment performed in august.The physician asked her to contact the treating nurse (the reporter).According to the nurse, the patient had not contacted her before this, but she contacted the nurse in (b)(6) 2017 after having met a dermatologist.New swelling in the middle of (b)(6) 2017 in the left cheek and around left eye.The nurse met the patient on (b)(6) 2017 and there was no on-going inflammation at that time.On the day of the report, (b)(6) 2017, the patient had a swelling again on the right cheek.On receipt of follow-up 2 on (b)(6) 2017, the case was upgraded to unanticipated status due to the persistence of the events for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.On the day of the initial report (b)(6) 2017), the patient has two really ugly scar on the cheek(implant site scar) where they opened up.On the other cheek she has a dark spot.No infection.The patient thinks she had some sort of allergic reaction(hypersensitivity) to the treatment.The situation is under control.No infection, no abscesses or similar for quite a while.The reporter thought of injecting hyalase, but has waited with that since she is unsure if the problems are due to the treatment.The patient claims that the clinic has "not informed me that injections with hyaluronic acid under the skin can cause adverse reactions for some people, as abscesses, redness in the skin and swelling".Follow up information received on 28-mar-2018 from the patient.The patient stated that: "i have still not recovered.I attach pictures taken yesterday.A few weeks ago, i got an abscess on the right side towards the temple.It is now about to decline.On the left side i have several scars." outcome at the time of the report: swelling was not recovered/not resolved.Abscess with pus was recovering/resolving.Allergic reaction was recovering/resolving.Possible inflammation was recovering/resolving.Scars on the cheek was not recovered/not resolved.Tracking list: v.0 initial and fu from (b)(6) 2017 and (b)(6) 2017.V.1 opened to create the final mir.No new information provided by the reporter in the follow-up attempts.V.2 fu received on 19-mar-2018 and 28-mar-2018 by the patient.The patient provided a description of the problems (similar to the description from the reporting nurse).
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Manufacturer Narrative
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Q-med ab, manufacturer, registration no.(b)(4).Se17009583 follow-up 2 report.Capa: the ifu precaution section includes information that injection procedures are associated with a risk of infection.Aseptic technique and standard practice to prevent cross-infections are to be observed.The company will closely monitor cases of infection that are reported with these products.Manufacturing narrative: lot number was not reported.Pharmacovigilance comments: the serious events of abscess, hypersensitivity and swelling were considered unexpected and possibly related to the treatment.The serious events of inflammation and implant site scar were considered expected and possibly related to the treatment.The abscess, hypersensitivity and swelling events were considered unexpected due to persistence for more than one year despite multiple emergency department and dermatology visits, antibiotic treatments and incision and drainage procedures.Serious criteria included permanent damage for scarring, and medical intervention to prevent permanent damage for the remaining events.Potential contributory factors for the events include an inflammatory reaction associated with preexisting dermal filler implants.Implants by unauthorized users might also have contributed to the reported events.An association with these events is less substantiated for restylane refyne because it was not implanted in the sites where the events occurred.The adverse event report meets the regulatory criteria for expedited reporting to the regulatory authorities.Additional comments: it was not reported if the device was available for the manufacturer to assess.
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Search Alerts/Recalls
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