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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA Q-MED RESTYLANE SILK; IMPLANT, DERMAL, FOR AESTHETIC USE
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GALDERMA Q-MED RESTYLANE SILK; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 16744
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Occlusion (1984); Pain (1994); Skin Discoloration (2074); Discomfort (2330); Pallor (2468); No Code Available (3191)
Event Date 09/23/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturer narrative: the reported lot number was valid.Capa comment: 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.Pharmacovigilance comment: the serious event of vascular occlusion was considered expected and possibly related to the treatment.The non-serious expected events of pallor, discolouration, pain, discomfort, bruising, pustules, papules at the implant site were considered possibly related to the treatment.Potential contributory factors include injection technique and off label injection in the glabellar area.The seriousness criteria included the medical intervention required to dissolve the potential vascular occlusion that appeared to cause secondary symptoms such as discoloration and pustules.The case did meet the seriousness criteria for expedited reporting to the regulatory authorities.
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on 27-sep-2019 by a physician which refers to a (b)(6) caucasian female patient.No information about medical history or history of allergies has been provided.Concomitant treatments included dysport injection, 50 units to glabellar area on (b)(6) 2019 and also on (b)(6) 2019.The patient had previously received treatment with unspecified filler and toxins.On (b)(6) 2019, the patient received treatment with 1 ml restylane silk (lot 16744) to glabellar area 0.05 ml (off label use), rest into perioral area with cannula and unknown technique.Same day, on (b)(6) 2019, the patient experienced blanching (implant site pallor) around the artery in forehead and then it went away.The patient also had discoloration (dusky, reddish)(implant site discolouration) to glabellar area.The hcp rubbed the area and it appeared to improve.The physician thought there was a possible occlusion (vascular occlusion).3 days later, on (b)(6) 2019, the patient experienced pain/tenderness (implant site pain), pressure(injection site discomfort) and looked a little dusky.Then patient developed pustules (implant site pustules).The patient also experienced bruising (implant site bruising) to glabella and around the eyes and also had a few papules (implant site papules) just above the injection site following the line of the artery.The hcp treated patient with hylenex [hyaluronidase] 600 units and gave aspirin [acetylsalicylic acid] 325 mg and told her to continue taking aspirin 80 mg daily.The pain and pressure have subsided but she still has some tenderness around the hairline even after physician gave 600 units of hylenex.The hcp also treated her with an ozone bag too.It was reported that physician was finding out, whether patient needs more hylanex since she still has tenderness around that artery.The patient also said it was feeling better that day compared to before, although it looks worse than before.Outcome at the time of the report: blanching was recovered/resolved.Discoloration (dusky, reddish) was unknown.Pain/tenderness was not recovered/not resolved.Pressure was recovered/resolved.Pustules was unknown.Possible occlusion was unknown.Bruising was not recovered/not resolved.Papules was not recovered/not resolved.Restylane silk injected to glabellar area was recovered/resolved.
 
Manufacturer Narrative
Manufacturer narrative: the reported lot number was valid.Capa comment: 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.Pharmacovigilance comment: the serious event of vascular occlusion was considered expected and possibly related to the treatment.The non-serious expected events of pallor, discolouration, pain, discomfort, bruising, pustules, papules at the implant site were considered possibly related to the treatment.Potential contributory factors include injection technique and off label injection in the glabellar area.The seriousness criteria included the medical intervention required to dissolve the potential vascular occlusion that appeared to cause secondary symptoms such as discoloration and pustules.The case did meet the seriousness criteria for expedited reporting to the regulatory authorities.
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on 27-sep-2019 by a physician which refers to a 41-year-old female patient.No information about medical history or history of allergies has been provided as reporter was unaware of it.Concomitant treatments included dysport injection, 50 units to glabellar area on (b)(6) 2019 and also on (b)(6) 2019.The patient had previously received treatment with unspecified filler and toxins.On (b)(6) 2019, the patient received treatment with 1 ml restylane silk (lot 16744) to 0.2 ml to glabella (off label use), 0.2 ml oral commissure, 0.2 ml to nasolabial area (on each side) with 30 and half cannula needle and retro injection technique.Same day, on (b)(6) 2019, the patient experienced blanching (implant site pallor) around the artery in glabella in right side and then it went away.The patient also had discoloration (dusky, reddish)(implant site discolouration) to glabellar area.The hcp rubbed the area and it appeared to improve.The physician thought there was a possible occlusion (vascular occlusion).3 days later, on (b)(6) 2019, the patient experienced pain/tenderness (implant site pain), pressure(injection site discomfort) and looked a little dusky.Then patient developed pustules (implant site pustules).The patient also experienced bruising (implant site bruising) to glabella and around the eyes and also had a few papules (implant site papules) just above the injection site following the line of the artery.The hcp treated patient with hylenex [hyaluronidase] 600 units on (b)(6) 2019 and gave aspirin [acetylsalicylic acid] 325 mg and told her to continue taking aspirin 80mg daily.The pain and pressure have subsided but she still has some tenderness around the hairline even after physician gave 600 units of hylenex.The hcp injected with a cannula with lidocaine [lidocaine] and also treated her with an ozone bag too.It was reported that physician was finding out, whether patient needs more hylanex since she still has tenderness around that artery.The patient also said it was feeling better that day compared to before, although it looks worse than before.The patient also applied daily topical manuka honey [manuka honey], prp and ozone bag from (b)(6) 2019 to (b)(6) 2019 and there was complete resolution.Outcome at the time of the report: possible occlusion was recovered/resolved.Blanching was recovered/resolved.Discoloration (dusky, reddish) was recovered/resolved.Pain/tenderness was recovered/resolved.Pressure was recovered/resolved.Pustules was recovered/resolved.Bruising was recovered/resolved.Papules was recovered/resolved.Restylane silk injected to glabellar area was recovered/resolved.Tracking list: v.0 initial.V.1 fu received on (b)(6) 2019 from physician.Patient demographic details, suspect device location, volume, needle type, injection technique, event severity, location, outcome and corrective treatment details were updated.
 
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Brand Name
RESTYLANE SILK
Type of Device
IMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW  SE-752 28
MDR Report Key9203486
MDR Text Key162867078
Report Number9710154-2019-00091
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P040024/S072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date10/31/2021
Device Lot Number16744
Was Device Available for Evaluation? No
Date Manufacturer Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DYSPORT.
Patient Outcome(s) Required Intervention;
Patient Age41 YR
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