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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA Q-MED RESTYLANE REFYNE IMPLANT, DERMAL, FOR AESTHETIC USE

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GALDERMA Q-MED RESTYLANE REFYNE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 14775-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Hypersensitivity/Allergic reaction (1907); Scarring (2061); Sepsis (2067); Swelling (2091); Skin Inflammation (2443)
Event Type  Injury  
Manufacturer Narrative
(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. 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. 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. 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. It was not reported if the device was available for the manufacturer to assess.
 
Event Description
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 (b)(6) 2017 and (b)(6) 2017. V. 1 23-nov-2017 opened to create the final mir. No new information provided by the reporter in the follow-up attempts.
 
Manufacturer Narrative
(b)(4) (importer) is submitting on behalf of q-med ab (manufacturer) (b)(4). Q-med ab, manufacturer. (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. Manufacturing narrative: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. 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. 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. 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.
 
Event Description
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)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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Brand NameRESTYLANE REFYNE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminarlegatan 21
uppsala se-772 28,
SW
Manufacturer (Section G)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer Contact
amy poteate
14501 n. freeway
fort worth, TX 76177
MDR Report Key6993619
MDR Text Key269860725
Report Number9710154-2017-00089
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P140029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/28/2017,06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Lot Number14775-1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA11/28/2017
Distributor Facility Aware Date11/28/2017
Event Location Other
Date Report to Manufacturer11/23/2017
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/01/2017 Patient Sequence Number: 1
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