MAUDE Adverse Event Report: GALDERMA Q-MED AB RESTYLANE KYSSE; IMPLANT, DERMAL, FOR AESTHETIC USE (LMH)

Lot Number 15946-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Scar Tissue (2060); Swelling (2091); Deformity/ Disfigurement (2360); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious events of mass at implant site and the non-serious events of cutaneous contour deformity, swelling and bruising at implant site were considered expected and possibly related to the treatment.The serious, expected event of scar at implant site and the non-serious, unexpected event of oral papilloma were considered unrelated to the treatment.Serious criteria include the need for medical interventions and permanent damage.Potential contributory factors for the related events include injection technique.Alternative etiologies for the scarring include the puncture removal technique of the white dots or oral papilloma.The oral papilloma were likely caused by (b)(6) infection and the black dots are typically blood vessels and small clots inside of the lesions.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.Manufacturing narrative: 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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2019 by a (b)(6) year old female patient concerning herself.Additional information was received on 29-oct-2019, 05-nov-2019,19-nov-2019 and 28-jan-2020 from same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.The patient never had such dots before; her lips had always had a nice rosy colour.On (b)(6) 2019, the patient received treatment with 0.7 ml restylane kysse (lot 15946-1) to lips (0.4 ml in upper lip and 0.3 ml in lower lip) using an unknown needle type and injection technique.On (b)(6) 2019, the patient contacted the galderma employee and stated that now that she had let all swelling (implant site swelling) and bruises (implant site bruising) heal, she was very uncomfortable and worried about the result.She had gotten a fishlip with rough lines(cutaneous contour deformity), especially from the corner of the mouth and forward, disproportionally much material in the middle compared to the sides and lower lip, as well as a small plug in the middle of the upper lip downwards, which looked really strange.On (b)(6) 2019, she had been to a physician and they had discussed a plan to fix the lips.The physician had injected the worst lumps (implant site mass) with some hyalase [hyaluronidase], with the hope of also removing the small white dots/warts with black colour in the middle (oral papilloma) that had emerged on both sides of the upper lip.According to the patient, the physician did not know why or how they had appeared or why they had not disappeared, since he had never seen anything like it.The patient further informed that she was going to see the physician again.The patient went to physician to evaluate the effect of the hyalase and to discuss what else that could be done.The patient stated that she was really worried about her lips, especially the warts that were clearly visible in profile, with open and closed mouth and also when wearing lipstick, but also the shape, no contour, the fish shape of the upper lip, the plug in the middle of the upper lip.The patient also stated that the lower lip was not a disaster but clearly uneven.The patient stated that she had wanted to await providing feedback until the bruises and swelling had gone down, which they now had.According to the patient, the effect of the hyalase and the new filler could now be seen it had become better but it was still uneven and another round would be needed to correct properly.The patient wanted to book another appointment with the physician, to get evenness, volume and contour to the lips.The patient had an appointment booked in (b)(6) 2019 with the physician for correction and to remove the white dots that had appeared, but the physician had to reschedule the appointment to (b)(6) 2020.The patient was feeling bad about her lips, she did not like her appearance at all and she was quite dejected.The hyalase treatment had not turned out well and the reconstruction was what the patient considered catastrophic, uneven and looked bad in every angle, also with her mouth open.She experienced it really challenging with all the white dots that was ruining her lips.There were so many now.She had never before had such dots and her lips had always had a nice rosy colour.Now she could not leave the house without wearing a full coverage lipstick.According to the patient, the physician had punctured some of the dots with a fine needle.The patient also stated that it felt quite psychologically difficult in regards to the scarring, the execution and the result that had not improved in several months.As per follow up information received on 22-jun-2020, the patient felt bad over the fact that she experienced that her lips look awful, she was especially unhappy with the texture, but also with the shape.The patient still had small dots and some scars(implant site scar) (possibly from dots the physician tried to remove).According to the patient, her lips and face look catastrophic with scars, dots that seem to remain permanent and an unevenness that was extremely hard to live with.She really did not feel good about this and that it had been going on for so long now.The patient did not feel that the help from the physician was going well.As per follow up information received on 23-jun-2020 from the physician, who provided the journal from the patient's appointment on (b)(6) 2020, who had come for discussions about lips.As per physician, the whole look was good, her sister who was a nurse had injected a little centrally in the lower lip.After discussion, physician agreed to place some filler to the right of the middle line in the upper lip.Patient had quite firm lips and physician do not think that one should inject more but to let it be as it was or perhaps even remove the filler.Outcome at the time of the report: lumps was not recovered/not resolved.Scars was not recovered/not resolved.Swelling was recovered/resolved.Bruises was recovered/resolved.White dots/warts with black colour in the middle was not recovered/not resolved.Fishlip with rough lines was unknown.Tracking list: v.0 initial v.1 fu received on 22-jun-2020 from the patient and from physician on 23-jun-2020.Events (scar, fishlip with rough lines) were added.Outcome of event dots was updated.Photo of lips received (no visible events).Case was medically confirmed and upgraded to serious.

Manufacturer Narrative

Pharmacovigilance comment: the serious event of mass at implant site and the non-serious events of cutaneous contour deformity, swelling and bruising at implant site were considered expected and possibly related to the treatment.The serious, expected event of scar at implant site and the non-serious, unexpected event of oral papilloma were considered unrelated to the treatment.Serious criteria include the need for medical interventions and permanent damage.Potential root cause for the related events include injection technique.Alternative etiologies for the scarring include the puncture removal technique of the white dots or oral papilloma.The oral papilloma were likely caused by human papilloma virus infection and the black dots are typically blood vessels and small clots inside of the lesions.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.Manufacturer narrative: 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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 24-oct-2019 by a 30-year-old female patient concerning herself.Additional information was received on (b)(6) 2019, (b)(6) 2019,(b)(6) 2019 and (b)(6) 2020 from same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.The patient never had such dots before; her lips had always had a nice rosy colour.On (b)(6) 2019, the patient received treatment with 0.7 ml restylane kysse (lot 15946-1) to lips (0.4 ml in upper lip and 0.3 ml in lower lip) using an unknown needle type and injection technique.On (b)(6) 2019, the patient contacted the galderma employee and stated that now that she had let all swelling (implant site swelling) and bruises (implant site bruising) heal, she was very uncomfortable and worried about the result.She had gotten a fishlip with rough lines/small irregularities(cutaneous contour deformity), especially from the corner of the mouth and forward, disproportionally much material in the middle compared to the sides and lower lip, as well as a small plug in the middle of the upper lip downwards, which looked really strange.On (b)(6) 2019, she had been to a physician and they had discussed a plan to fix the lips.The physician had injected the worst lumps (implant site mass) with some hyalase [hyaluronidase], with the hope of also removing the small white dots/warts with black colour in the middle (oral papilloma) that had emerged on both sides of the upper lip.According to the patient, the physician did not know why or how they had appeared or why they had not disappeared, since he had never seen anything like it.The patient further informed that she was going to see the physician again.The patient went to physician to evaluate the effect of the hyalase and to discuss what else that could be done.The patient stated that she was really worried about her lips, especially the warts that were clearly visible in profile, with open and closed mouth and also when wearing lipstick, but also the shape, no contour, the fish shape of the upper lip, the plug in the middle of the upper lip.The patient also stated that the lower lip was not a disaster but clearly uneven.The patient stated that she had wanted to await providing feedback until the bruises and swelling had gone down, which they now had.According to the patient, the effect of the hyalase and the new filler could now be seen it had become better but it was still uneven and another round would be needed to correct properly.The patient wanted to book another appointment with the physician, to get evenness, volume and contour to the lips.The patient had an appointment booked in (b)(6) 2019 with the physician for correction and to remove the white dots that had appeared, but the physician had to reschedule the appointment to (b)(6) 2020.The patient was feeling bad about her lips, she did not like her appearance at all and she was quite dejected.The hyalase treatment had not turned out well and the reconstruction was what the patient considered catastrophic, uneven and looked bad in every angle, also with her mouth open.She experienced it really challenging with all the white dots that was ruining her lips.There were so many now.She had never before had such dots and her lips had always had a nice rosy colour.Now she could not leave the house without wearing a full coverage lipstick.According to the patient, the physician had punctured some of the dots with a fine needle.The patient also stated that it felt quite psychologically difficult in regards to the scarring, the execution and the result that had not improved in several months.As per follow up information received on (b)(6) 2020, the patient felt bad over the fact that she experienced that her lips look awful, she was especially unhappy with the texture, but also with the shape.The patient still had small dots and some scars (implant site scar) (possibly from dots the physician tried to remove).According to the patient, her lips and face look catastrophic with scars, dots that seem to remain permanent and an unevenness that was extremely hard to live with.She really did not feel good about this and that it had been going on for so long now.The patient did not feel that the help from the physician was going well.As per follow up information received on (b)(6) 2020 from the physician, who provided the journal from the patient's appointment on (b)(6) 2020, who had come for discussions about lips.As per physician, the whole look was good, her sister who was a nurse had injected a little centrally in the lower lip.After discussion, physician agreed to place some filler to the right of the middle line in the upper lip.Patient had quite firm lips and physician do not think that one should inject more but to let it be as it was or perhaps even remove the filler.As per follow up information received on (b)(6) 2020, patient reported that after some follow-ups with physician, the she still had problems.The patient had not received feedback and plan of action.As follow up information on (b)(6) 2020, physician meeting notes from (b)(6) 2020 were received.They discussed regarding the patient's lips and the small irregularities that exist in the transition between the mucosa and the red of the lip laterally on upper lip.No one had any treatment suggestions.They thought that they would discuss the problem possibly with a dermatologist.Outcome at the time of the report: lumps was not recovered/not resolved.Scars was not recovered/not resolved.Swelling was recovered/resolved.Bruises was recovered/resolved.White dots/warts with black colour in the middle was not recovered/not resolved.Fishlip with rough lines/small irregularities was not recovered/not resolved.Tracking list: v.0 initial v.1 fu received on (b)(6) 2020 from the patient and from physician on (b)(6) 2020.Events (scar, fishlip with rough lines) were added.Outcome of event dots was updated.Photo of lips received (no visible events).Case was medically confirmed and upgraded to serious.V.2 fu received on (b)(6) 2020 from the patient and on (b)(6) 2020 from physician: verbatim of event cutaneous contour deformity and outcome were updated.

• Brand Name: RESTYLANE KYSSE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE (LMH)
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 10302411
• MDR Text Key: 207927754
• Report Number: 9710154-2020-00062
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P140029/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Lot Number: 15946-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO INFORMATION; NO INFORMATION
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 30 YR