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| Lot Number 18685-1 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Subcutaneous Nodule (4548); Nodule (4551); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 08/19/2021 |
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Event Type
Injury
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 22-oct-2022 by a physician which refers to a female patient of an unknown age.Additional information was received from another physician and patient herself.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.The patient had a dental filling prior to the filler treatment and need to have a crown placed.On an unknown date, the patient received treatment with restylane defyne, restylane refyne and restylane skinbooster vital using an unspecified cannula (unknown amount, lot number, injection technique) to an unknown location.The procedure was performed by another physician during a workshop.On (b)(6) 2021, the sales representative (sr) visited the trainer physician.The physician thought the patient had an infection (implant site infection).She hyalased [hyaluronidase] the area and prescribed unspecified antibiotics.According to reporter, the patient was fine and also that she did not believe that it was the product but probably the injecting physician touching the cannulas.On (b)(6) 2021, the physician was hesitant to complete the adr form as the situation was under control.She again said that it was not the product.The trainer physician did not let injecting physician know that the patient he injected had an issue.On (b)(6) 2021, the physician contacted the sr and informed that she was feeling unsettled about patient and asked if she could arrange for her to consult another local mentor trainer and sr did the same.Same day, the sr received message from the patient, she was very concerned as the wound (around the entry point of the cannula) started oozing with puss (purulent discharge).The patient contacted the injecting physician.On (b)(6) 2021, the patient consulted another local mentor trainer and there were no open active lesions and it looked like she was healing nicely.The physician asked the patient if she had dental work done recently and the patient said that she has had a dental filling prior to the filler treatment and need to have a crown but had not been back as the infection occurred.The physician suggested that the patient should get scan done to rule out any underlying dental infection and additional tests to rule out any systemic issues.He also asked the patient when she went for her vaccine and she could not remember the exact date but it was borderline close.The patient was advised not to have any filler and toxin treatment.On (b)(6) 2021, the physician contacted the sr and she was not happy with the advice provided by another local mentor trainer.On (b)(6) 2021, the injecting physician reported to the sr that he was upset with the physician trainer that she did not informed him of the situation.He assessed the patient again, there were no open pustular lesions.He hyalased as well and gave the patient more antibiotics.On (b)(6) 2021, the injecting physician received feedback from physician trainer, everything was fine and she was much better.The next day after the hyalase treatment, some of those chronic abscess (implant site abscess) were drained.Swab was taken by the lab and results showed no bacteria growth.According to the injecting physician, the infection seems to have settled, which would help to hyalase.On (b)(6) 2021, the injecting physician informed sr that the patient had another abscess anhttps://emdr.Fda.Gov/emdr/forminbox/d was unsure of course of action, possibly they might admit patient and administer iv antibiotics and ultrasound to establish where the filler was.The patient will discuss with the physician (her daughter).Outcome at the time of the report: chronic abscess was not recovered/not resolved.Infection was not recovered/not resolved.Oozing with puss was recovered/resolved.
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Manufacturer Narrative
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Company comment: the serious events of infection and abscess at implant site and the non-serious event of purulent discharge were considered expected and possibly related to the treatments.Serious criteria include the need for medical interventions including drainage to prevent permanent damage.The potential root cause include injection procedure associated with inadequate aseptic technique.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: restylane refyne-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 preventive action: restylane refyne-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.
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Manufacturer Narrative
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Company comment: the serious events of infection, inflammation, nodule, scar and abscess at implant site and the non-serious events of swelling, pain, induration at implant site and purulent discharge were considered expected and possibly related to the treatments.Serious criteria include the need for medical and surgical interventions including permanent damage.The potential root cause include injection procedure associated with inadequate aseptic technique.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: restylane contour-routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to galderma quality management system.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 preventive action: restylane contour-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by a physician which refers to a 73 year-old female patient.Additional information was received from another physician and patient herself.No information about medical history, concomitant medication or history of allergies had been provided.The patient had previously received treatment with unspecified fillers without experiencing adverse effects.The last recorded filler treatment was more than a year ago with no recent treatments.The patient had a dental filling prior to the filler treatment and needed to have a crown placed.On (b)(6) 2021, the patient had received an unspecified covid-19 vaccine and good eight weeks period was allowed between vaccination and filler treatment.At the time of the filler treatment, the patient was clinically well, did not have any acute sinusitis, any indication of urine tract infection and had no acute or chronic dental infections or abscesses.A report to such with x-rays was available.The patient was a fit and healthy female at the time with a temperature of 36.4°c on the day, monitored patient on routine screening as per covid protocol.The patient was asymptomatic for any covid symptoms.Before the filler treatment, all make up was removed with cleanser.The skin was disinfected with chlorhexadine in 70% alcohol [chlorhexidine gluconate, ethanol].On (b)(6) 2021, the patient received treatments with 1 ml restylane defyne (lot 19152-1), 0.5 ml per side of mid-face or cheek area in the deep fat pads (deep medial fat pad, and medial and lateral soof) using a cannula co-packed with syringe and 1 ml of restylane volyme (lot 18685-1), 0.5 ml per side of mid-face or cheek area in the subcutaneous tissue using an apparent sterile 50mm 25g cannula.The procedure was performed during a clinical setting workshop training by a physician using a retrograde fanning technique.The injection technique was good at the time and due care and warning was issued not to touch the cannula at the entrance point, or along the cannula.On (b)(6) 2021, the patient experienced acute onset inflammatory (implant site inflammation) nodules (implant site nodule) bilateral on cheeks.The inflammatory nodules were swollen (implant site swelling), painful (implant site pain) indurated and hard (implant site induration).According to the trainer physician, assessment clinically appeared to be an infection (implant site infection) and the patient was put on antibiotics levofloxacin [levofloxacin] 500 mg twice a day for 10 days and clarithromycin [clarithromycin] 500 mg per oral daily for 10 days and then continued with ciprobay [ciprofloxacin] for 6 weeks.The patient also received treatment with a short course of prednisone [prednisone], unspecified antihistamine and anti-inflammatory agents.The inflammation continued to spread to the whole cheek area and multiple abscesses (implant site abscess) started to form.As indicated, the incision and drainage was done by physician under local anaesthetic for various indurated abscesses.The wound (around the entry point of the cannula) started oozing with pus (purulent discharge).The pus swabs were sent for culture, which had pus cells but there was no bacterial growth.The abscess started on the left cheek at first but then started to develop on the right side as well.Apart from performing incision and drainage techniques on the abscesses, two treatments of hylase [hyaluronidase] were administered two days apart.The full 1500 mg of hylase was used for each treatment.The hylase was injected at a time when the physician felt that the hardness and integration was at its most intense.About two weeks later, the left side of the cheek started to clear up but the right side continued to develop abscesses.Two or three days after, the left side flared up again.The third treatment with hylase was performed in the morning before the trainer physician emigrated from south africa.On (b)(6) 2021, the physician saw patient, who did nothing to the patient and did not examine her.The physician told the patient that the situation had arisen because she had a sinus infection at the time.The patient was prescribed unspecified nasal spray and was told that if it was not sinusitis it was probably an uti or dental infection and advised her to see her dentist.The trainer physician contacted the actual injecting physician and requested to assist since he was a dermatologist and management of soft tissue infections would be routine for him.According to the reporting physician, the problem occurred due to touching of the cannula.The galderma supplied 50mm 38mm cannulas for the training and the learning doctors used to keep touching them.The injecting physician started corrective treatment with augmentin [amoxicillin sodium, clavulanic acid] 2 gram twice a day for 10 days again and would follow up until the issue resolved.In (b)(6) 2021, a few small lesions appeared, then seemed to have settled in (b)(6) 2021 but flared up again aggressively in (b)(6) 2022.The injecting physician declined to further follow up the patient and asked to contact her gp.The trainer physician referred the patient to the plastic surgeon, she did not do much but gave patient some plasters to put on for 5 days at a time and advised to come back and see her for grafting and fat filling when it was all gone.On (b)(6) 2022, the injecting physician informed the sales representative that the patient had another abscess and was unsure of course of action, possibly they might admit patient and administer iv antibiotics and ultrasound to establish where the filler was.The patient will discuss with the trainer physician (her daughter).According to the trainer physician, the patient's condition looked so bad, the hard nodules became softer, burst-drained and settled, then new abscesses developed then bust open and cycles were repeated.The patient situation was still ongoing and multiple acute abscesses continued to develop with ongoing chronic abscesses.The patient had severe scarring (implant site scar) and loss of tissue.She was in extreme mental distress and had ongoing pain.Outcome at the time of the report: abscesses was not recovered/not resolved.Infection was not recovered/not resolved.Inflammatory was not recovered/not resolved.Nodules was not recovered/not resolved.Scarring was not recovered/not resolved.Oozing with puss was recovered/resolved.Swollen was unknown.Painful was unknown.Indurated and hard was unknown.Tracking list: v.0 initial v.1 fu received on (b)(6) 2022 from a physician: events (implant site inflammation, nodule, scarring, pain, swelling and induration) and patient's age added.Suspect device restylane volyme added and restylane skinbooster vital and restylane refyne were removed.Historical vaccine, restylane defyne implant location, volume, needle type, injection technique, lot number, expiry date, event onset date, severity, outcome, reporter causality and corrective treatment details were updated.V.2 results were received from repeated batch record reviews on (b)(6) 2022.
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Manufacturer Narrative
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Company comment: the serious events of infection, inflammation, nodule, scar and abscess at implant site and the non-serious events of swelling, pain, induration at implant site and purulent discharge were considered expected and possibly related to the treatments.Serious criteria include the need for medical and surgical interventions to prevent permanent damage.The potential root cause include injection procedure associated with inadequate aseptic technique.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: restylane contour- routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to galderma quality management system.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 preventive action: restylane contour-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 22-oct-2021 by a physician which refers to a 73-year-old female patient.Additional information was received from another physician and patient herself.No information about medical history, concomitant medication or history of allergies had been provided.The patient had previously received treatment with unspecified fillers without experiencing adverse effects.The last recorded filler treatment was more than a year ago with no recent treatments.The patient had a dental filling prior to the filler treatment and needed to have a crown placed.On (b)(6) 2021, the patient had received an unspecified covid-19 vaccine and good eight weeks period was allowed between vaccination and filler treatment.At the time of the filler treatment, the patient was clinically well, did not have any acute sinusitis, any indication of urine tract infection and had no acute or chronic dental infections or abscesses.A report to such with x-rays was available.The patient was a fit and healthy female at the time with a temperature of 36.4°c on the day, monitored patient on routine screening as per covid protocol.The patient was asymptomatic for any covid symptoms.Before the filler treatment, all make up was removed with cleanser.The skin was disinfected with chlorhexadine in 70% alcohol [chlorhexidine gluconate, ethanol].On (b)(6) 2021, the patient received treatments with 1 ml restylane defyne (lot 19152-1), 0.5 ml per side of mid-face or cheek area in the deep fat pads (deep medial fat pad, and medial and lateral soof) using a cannula co-packed with syringe and 1 ml of restylane volyme (lot 18685-1), 0.5 ml per side of mid-face or cheek area in the subcutaneous tissue using an apparent sterile 50mm 25g cannula.The procedure was performed during a clinical setting workshop training by a physician using a retrograde fanning technique.The injection technique was good at the time and due care and warning was issued not to touch the cannula at the entrance point, or along the cannula.On (b)(6) 2021, the patient experienced acute onset inflammatory (implant site inflammation) nodules (implant site nodule) bilateral on cheeks.The inflammatory nodules were swollen (implant site swelling), painful (implant site pain) indurated and hard (implant site induration).According to the trainer physician, assessment clinically appeared to be an infection (implant site infection) and the patient was put on antibiotics levofloxacin [levofloxacin] 500 mg twice a day for 10 days and clarithromycin [clarithromycin] 500 mg per oral daily for 10 days and then continued with ciprobay [ciprofloxacin] for 6 weeks.The patient also received treatment with a short course of prednisone [prednisone], unspecified antihistamine and anti-inflammatory agents.The inflammation continued to spread to the whole cheek area and multiple abscesses (implant site abscess) started to form.As indicated, the incision and drainage was done by physician under local anaesthetic for various indurated abscesses.The wound (around the entry point of the cannula) started oozing with pus (purulent discharge).The pus swabs were sent for culture, which had pus cells but there was no bacterial growth.The abscess started on the left cheek at first but then started to develop on the right side as well.Apart from performing incision and drainage techniques on the abscesses, two treatments of hylase [hyaluronidase] were administered two days apart.The full 1500 mg of hylase was used for each treatment.The hylase was injected at a time when the physician felt that the hardness and integration was at its most intense.About two weeks later, the left side of the cheek started to clear up but the right side continued to develop abscesses.Two or three days after, the left side flared up again.The third treatment with hylase was performed in the morning before the trainer physician emigrated from south africa.On (b)(6) 2021, the physician saw patient, who did nothing to the patient and did not examine her.The physician told the patient that the situation had arisen because she had a sinus infection at the time.The patient was prescribed unspecified nasal spray and was told that if it was not sinusitis it was probably an uti or dental infection and advised her to see her dentist.The trainer physician contacted the actual injecting physician and requested to assist since the injecting physician was a dermatologist and management of soft tissue infections would be routine for him.According to the reporting physician, the problem occurred due to touching of the cannula.The galderma supplied 50mm 38mm cannulas for the training and the learning doctors used to keep touching them.The injecting physician started corrective treatment with augmentin [amoxicillin sodium, clavulanic acid] 2 gram twice a day for 10 days again and would follow up until the issue resolved.In (b)(6) 2021, a few small lesions appeared, then seemed to have settled in (b)(6) 2021 but flared up again aggressively in jan-2022.The injecting physician declined to further follow up the patient and asked to contact her gp.The trainer physician referred the patient to the plastic surgeon, she did not do much but gave patient some plasters to put on for 5 days at a time and advised to come back and see her for grafting and fat filling when it was all gone.On (b)(6) 2022, the injecting physician informed the sales representative that the patient had another abscess and was unsure of course of action, possibly they might admit patient and administer iv antibiotics and ultrasound to establish where the filler was.The patient will discuss with the trainer physician (her daughter).According to the trainer physician, the patient's condition looked so bad, the hard nodules became softer, burst-drained and settled, then new abscesses developed then bust open and cycles were repeated.The patient situation was still ongoing and multiple acute abscesses continued to develop with ongoing chronic abscesses.The patient had severe scarring (implant site scar) and loss of tissue.She was in extreme mental distress and had ongoing pain.As per consultation on (b)(6) 2022, the treating physician reported that patient was initially seen twice weekly and responded very quickly to oral clarithromycin and local injections of amikacin [amikacin].The oral clarithromycin was withdrawn after a month and once weekly injections of amikacin was continued locally until (b)(6) 2022.Hyaluronidase perfusions were also provided together with the amikacin on occasions along the way.As per consultation on (b)(6) 2023, the treating physician reported that the patient had done extremely well.The patient had no signs of inflammation since (b)(6) 2022.Her soft tissue was healed and softened.There was no clinical sign of deep scarring, and she was clinically free of nodules or induration.The skin had some small superficial scarring.The right cheek had a soft skintag-like scar about 2.5mm in diameter.The left cheek had a small, depressed punctum tethered to deeper tissue.Both of these were at the site of previously draining sinuses, and they responded well to simple, superficial, scar excision.They were fully healed.Outcome at the time of the report: abscesses was recovered/resolved.Infection was recovered/resolved.Inflammatory was recovered/resolved.Nodules was recovered/resolved.Scarring was recovered/resolved.Oozing with puss was recovered/resolved.Swollen was recovered/resolved.Painful was recovered/resolved.Indurated and hard was recovered/resolved.Tracking list: v.0 initial v.1 fu received on 28-mar-2022 from a physician: events (implant site inflammation, nodule, scarring, pain, swelling and induration) and patient's age added.Suspect device restylane volyme added and restylane skinbooster vital and restylane refyne were removed.Historical vaccine, restylane defyne implant location, volume, needle type, injection technique, lot number, expiry date, event onset date, severity, outcome, reporter causality and corrective treatment details were updated.V.2 results were received from repeated batch record reviews on 07-apr-2022.V.3 fu received on 06-apr-2023 from the treating physician: information about corrective treatments and outcome of events was updated.Serious criteria of permanent damage was removed for the event of scarring.
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