MAUDE Adverse Event Report: GALDERMA QMED RESTYLANE; IMPLANT, DERMAL, FOR AESTHETIC USE

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

Patient Problems Swelling (2091); Tingling (2171); Discomfort (2330); No Code Available (3191)

Event Date 05/18/2016

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 narrative: lot number was not reported.Pharmacovigilance comment: the serious event of pharyngeal oedema was considered unexpected and possibly related to the treatments.Serious criteria include the need for medical intervention with epinephrine, antihistamines and intravenous cortisone to prevent permanent damage.The non-serious events of swelling at the implant site, pruritus, paraesthesia and discomfort were considered expected and possibly related to the treatments.Potential contributory factors for the event of pharyngeal oedema include allergic reactions to restylane nos, given her medical history of drug hypersensitivity.The case meets the criteria for expedited reporting to the regulatory authorities.Exemption: (b)(4).

Event Description

Case reference number (b)(4) is a spontaneous report sent on 09-mar-2018 via a medical enquiry to the company from a (b)(4) female consumer.The patient reported her own case.The patient's concurrent disease include mac (mycobacterium avium complex), a disease in the airways the patient received after having pneumonia several times in the past.The patient was also allergic to benzoates and acetylsalicylic acid.Concomitant treatments included azithromycin for the mac and cholesterol medicine [statin].The patient had previously received filler treatments with restylane to nose, chin and frown line on the forehead without experiencing any complications.The patient was treated with restylane nos a few years before (b)(6) 2016.On (b)(6) 2016 the patient received her last treatment.During both treatments the patient received restylane nos to the nose and chin (unknown amount, lot number, injection technique and needle type).Approximately, 10-15 minutes (as it usually takes for her allergy reactions to appear) after each of the two treatments that was performed a few years ago and on (b)(6) 2018, the patient experienced itchy hands and feet(pruritus), swelling in throat(pharyngeal oedema), swelling in the treated area(implant site swelling), tingling sensation(paraesthesia) and general discomfort(discomfort).The patient had to treat the reactions with antihistamine [antihistamines], cortisone and adrenaline [epinephrine].It was not reported if the corrective treatments were given after the treatment that was performed a few years ago, the last treatment on (b)(6) 2016 or after both of them.Following the last treatment on (b)(6) 2016, it became so bothersome that the patient urgently had to go to the hospital and get cortisone intravenously.The problems remained for several days, which was unusual for the patient.Thereafter, the patient recovered.At the time of the report the outcome of the adverse events was recovered/resolved.

• Brand Name: RESTYLANE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA QMED; seminarigatan 21; upsala, se-752 28 SE-75 2 28; SW SE-752 28
• Manufacturer Contact: lisa benaise ; seminarigatan 21; upsala, se-752 28 SE-75-2 28 ; SW SE-752 28
• MDR Report Key: 7374750
• MDR Text Key: 103663986
• Report Number: 9710154-2018-00024
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Distributor Facility Aware Date: 03/27/2018
• Date Report to Manufacturer: 03/09/2018
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR