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U.S. Department of Health and Human Services

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

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Q-MED RESTYLANE SILK IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 17319
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Cellulitis (1768); Cyst(s) (1800); Purulent Discharge (1812); Discomfort (2330); Skin Infection (4544); Swelling/ Edema (4577)
Event Date 01/17/2022
Event Type  Injury  
Event Description
Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2022 by an other health professional concerning a (b)(6) female patient. The patient was not pregnant. The patient had no known allergies. No information about medical history or previous filler treatments has been provided. Concomitant treatments included oral protonix [omeprazole]. On (b)(6) 2022, the patient received treatment with 1 ml restylane silk (lot 17319) to upper lip, 2 ml restylane lyft with lidocaine (lot 19673 and 19107),1 ml to each side of cheek and 1 ml restylane defyne (lot 19267) to left nasolabial fold with unknown injection technique and needle type. The patient also received juvederm brand filler to right nasolabial fold on the same day. In (b)(6) 2022, the patient experienced an extensive/massive reaction; facial cellulitis (implant site cellulitis) and facial swelling (implant site swelling). On (b)(6) 2022, the patient reported the events to the hcp. On (b)(6) 2022, the patient received first dose of iv daptomycin [daptomycin] antibiotics and received subsequent iv daptomycin doses from (b)(6) 2022 to present. On (b)(6) 2022, the patient was hospitalized at a medical center. On (b)(6) 2022, the patient will be discharged for surgical incision and drainage. Outcome at the time of the report: cellulitis was not recovered/not resolved/ongoing. Swelling was not recovered/not resolved/ongoing.
 
Manufacturer Narrative
Evaluation text: 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. 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. Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations. Company comment: the serious expected events of cellulitis and swelling at implant site were considered possibly related to the treatments. Serious criteria include the need for medical intervention and hospitalization to prevent permanent damage. The potential root cause include treatment procedure. The case meets the criteria for expedited reporting to the regulatory authorities.
 
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Brand NameRESTYLANE SILK
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
Q-MED
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer (Section G)
Q-MED
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer Contact
randy russell
14501 n. freeway
fort worth, TX 76177
MDR Report Key13546769
MDR Text Key290400110
Report Number9710154-2022-00006
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P040024/S072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Lot Number17319
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/16/2022 Patient Sequence Number: 1
Treatment
JUVEDERM; JUVEDERM; PROTONIX [OMEPRAZOLE]; PROTONIX [OMEPRAZOLE]; RESTYLANE DEFYNE; RESTYLANE DEFYNE; RESTYLANE LYFT WITH LIDOCAINE; RESTYLANE LYFT WITH LIDOCAINE
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