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

Lot Number UNKNOWN

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

Patient Problems Abscess (1690); Necrosis (1971); Pain (1994); Swelling (2091); Tingling (2171); No Code Available (3191)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Lot number was not reported.Pharmacovigilance comment: the serious events of cutaneous contour deformity, necrosis and abscess at the implant site and the non-serious events of paraesthesia, swelling and pain at the implant site were considered expected and possibly related to the treatment.Serious criteria includes the need for medical and surgical intervention including abscess removal and permanent damage.The cutaneous contour deformity was likely due to scarring and defects secondary to necrosis.Potential contributory factor include injection technique or improper aseptic precautions.The case meets the criteria for expedited reporting to the regulatory authorities.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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 18-oct-2019 by a (b)(6) female patient concerning herself.The patient medical history included seasonal allergies.The patient had previously received treatment with restylane on 2017.Concomitant treatment included zyrtec [zyrtec] as needed for seasonal allergies.On (b)(6) 2018, the patient received treatment with restylane to lips (unknown amount, lot number, needle type and injection technique).On (b)(6) 2018, immediately after treatment the patient experienced tingling/loss of feeling (implant site paraesthesia) at lips, increased swelling (implant site swelling), right lower lip was the size of a baseball and was painful (implant site pain).On (b)(6) 2018, the patient visited the urgent care and prescribed prednisone [prednisone], which did not help with the swelling.On an unknown date in 2018, the patient developed abscess (implant site abscess) and necrosis (implant site necrosis) at lip.On (b)(6) 2018, the patient visited the emergency room, and had undergone an abscess removal on the area.The patient was also prescribed an unspecified antibiotics.The patient reported that the swelling and pain had subsided.The patient was left with no feeling in her right lower lip and there was a dip in skin (cutaneous contour deformity) where the necrotic tissue was removed.Outcome at the time of the report: necrosis was recovering/resolving.Abscess was recovered/resolved.Dip in skin was not recovered/not resolved.Tingling/loss of feeling was not recovered/not resolved.Swelling was recovered/resolved.Pain was recovered/resolved.

• Brand Name: RESTYLANE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, se-752 28 ; SW
• Manufacturer (Section G): GALDERMA Q-MED; seminariegatan 21; uppsala, se-752 28 ; SW
• Manufacturer Contact: amy poteate ; 14501 north freeway; fort worth, TX 76177 ; 8175615353
• MDR Report Key: 9318019
• MDR Text Key: 185555296
• Report Number: 9710154-2019-00103
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 33 YR