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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED RESTYLANE-L IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 15708
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Cellulitis (1768); Erythema (1840); Pain (1994); Skin Discoloration (2074); Swelling (2091); Discomfort (2330); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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 comment: the reported lot number was valid. Pharmacovigilance comment: the serious events of cellulitis and foreign body reaction were considered expected and possibly related to the treatment. Serious criteria include the need for multiple medical interventions with multiple courses of iv antibiotics, oral antibiotics and hyaluronidase dissolution therapy. The non-serious events of implant site erythema, swelling, pain, warmth, discoloration and discomfort were considered expected and possibly related to the treatment. Potential contributory factors include injection technique. The non-serious event of clostridium difficile colitis was considered unexpected and unrelated to the treatment. Alternative etiologies for clostridium difficile colitis include multiple antibiotic courses. The case meets the seriousness criteria for expedited reporting to the regulatory authorities. (b)(4).
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2019 by a consumer/other non health professional which refers to a (b)(6) caucasian/hispanic female patient. The patient medical history included rosacea and allergies to latex. No information about concomitant medication has been provided. The patient had previously received treatment with restylane-l on an unknown date in (b)(6) 2017 and (b)(6) 2018. On (b)(6) 2018, the patient received treatment with 1 ml (right and left central cheek 0. 3 cc and 0. 2 cc rt and lt mouth) restylane lyft with lidocaine (lot 16114) into the cheeks and marionette lines with unknown needle and technique, and 1 ml restylane-l (lot 15708) into the cheeks and marionette lines with unknown needle and technique. Couple of days later, on an unknown date in (b)(6) 2018, the patient experienced red spot on right cheek/redness of cheek (implant site erythema). 1 month later, on an unknown date in (b)(6) 2018, the patient experienced significant swelling right upper cheek (implant site swelling), pain right upper cheek (implant site pain) and heat right upper cheek (implant site warmth), change in color of skin (implant site discolouration) and heaviness (discomfort). On (b)(6) 2018, the patient returned to injector and treated with hyaluronidase [hyaluronidase] and antibiotics, no improvement was seen. Again on (b)(6) 2018, patient was treated with hyaluronidase [hyaluronidase] and a 7 day course with 2 different antibiotics. On (b)(6) 2018, the patient visited to urgent care and underwent ct scan, which showed possible cellulitis (implant site cellulitis). The patient was given iv antibiotics for 2 days and oral antibiotics however when finished the course, the infection resumed. It was reported that till (b)(6) 2019, patient had received 14 days of intravenous antibiotics, a total of 5 - 6 different kinds of antibiotics. On an unknown date in (b)(6) 2019, the patient visited a infectious disease consultant, had mri which was negative for granulomas. Infectious disease consultant told it looks like a foreign body (foreign body reaction). On (b)(6) 2019, the patient developed clostridium difficile diarrhea (clostridium difficile colitis) and was put on vancomycin [vancomycin]. Outcome at the time of the report: red spot on right cheek/redness of cheek was recovered/resolved. Significant swelling right upper cheek was recovered/resolved. Pain right upper cheek was not recovered/not resolved. Heat right upper cheek was recovered/resolved. Cellulitis was not recovered/not resolved. Looks like a foreign body was not recovered/not resolved. Change in color of skin was not recovered/not resolved. Clostridium difficile diarrhea was not recovered/not resolved. Heaviness was not recovered/not resolved.
 
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Brand NameRESTYLANE-L
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer (Section G)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer Contact
amy poteate
14501 north freeway
fort worth, TX 76177
8175615353
MDR Report Key8456638
MDR Text Key140022605
Report Number9710154-2019-00017
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P040024/S039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Lot Number15708
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2019 Patient Sequence Number: 1
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