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

Lot Number 14959

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

Patient Problems Dyspnea (1816); Edema (1820); Foreign Body Reaction (1868); Rash (2033); Swelling (2091); No Code Available (3191)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious events of foreign body granuloma and implant site nodule, and the non-serious events of implant site oedema and swelling were considered expected and possibly related to both treatments.The serious, unexpected event of pharyngeal oedema, the non-serious, expected event of rash and the serious event of dyspnoea, expected for restylane lyft and unexpected for restylane refyne, were considered unlikely related to both treatments.Serious criteria for the granuloma and nodules included the need for surgical removal of the upper lip implant after unsuccessful medical intervention that included 5-fluorouracil, steroids, hyaluronidase, multiple antibiotics and antihistamines.The serious criteria for pharyngeal edema and dyspnoea related to urgent medical intervention in the emergency room, included the use of an epipen, steroid injection and h2 blockers to prevent possible anaphylaxis.The respiratory symptoms, rash and aggravation of facial and lip swelling were most likely caused by severe hypersensitivity to telithromycin antibiotic therapy since the drug was restarted one day prior to event onset.The filler and botulinum toxin were unlikely related to the respiratory and rash events as they were administered more than 15 weeks before event onset and were well tolerated after several past treatments.Potential contributory factors for the implant site reactions include overcorrection as there were five lip filler injections within a nine month period.Potential contributory factors for hypersensitivity included medical history of multiple allergies and possible allergy reported as gastrointestinal upset after telithromycin and cipromycin were started six weeks earlier.This case meets the criteria for expedited reporting to the regulatory authorities.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.No potential quality issues have been identified in the manufacturing process of the specified batches.The batches are manufactured and released according to (b)(4).Manufacturer narrative: the reported lot number was valid.(b)(4).

Event Description

Case reference number (b)(4) is a spontaneous report sent on 16-oct-2018 by a physician which refers to a (b)(6) female patient.The patient's medical history included hives from sulfa drugs, allergy to lavendar, allergic to imipramine, depression, and environmental allergies.The patient had previously received treatment with restylane refyne to the lips on (b)(6) 2017, (b)(6) 2017, and (b)(6) 2017.The patient also previously received restylane lyft with lidocaine to the cheeks and dysport 108 units total to the glabellar, perioral, and upper lip on (b)(6) 2018.On (b)(6) 2018, the patient received treatment with 1 ml of restylane refyne (lot 15677) to the lips and an unknown amount of restylane lyft with lidocaine (lot 14959) to an unknown location.Needle types and injection techniques were unknown.Concomitant treatment included dysport 108 units total to glabella, perioral, and upper lip.58 days later, on (b)(6) 2018, the patient experienced nodules (implant site nodule) in the upper lip.The event was treated by injecting 0.3 ml of hyaluronidase into the nodules.On (b)(6) 2018, a prescription was given for a medrol [methylprednisolone] dose pack, benadryl [diphenhydramine hydrochloride], cipro [ciprofloxacin] and telithromycin for 4 weeks.On (b)(6) 2018, the patient was seen for increased edema (implant site oedema) of the nodules in the lip.The event was treated by injecting 0.3 ml of hyaluronidase into the nodules.On (b)(6) 2018, the patient took tylenol [paracetamol] and felt a nodule in the right upper lip separate into two smaller nodules.The event was treated by injecting 0.5 ml of hyaluronidase into the nodules.On (b)(6) 2018, during follow up visit for monitoring, the patient was doing well.On (b)(6) 2018, the nodules were feeling firm again.The patient was injected with 1 ml of hyaluronidase to the nodules in the upper lip and 0.5 ml of hyaluronidase to the lower lip to dissolve the filler.No nodules were reported in the lower lip.On (b)(6) 2018, the patient's left side of the upper lip became larger than the right.The patient was injected with 0.1 ml of betamethasone to the nodules in the upper lip.On (b)(6) 2018, the nodules became worse.The physician attempted to aspirate; however, there was no return.The patient was treated with 0.1 ml of 5-fu [fluorouracil] and restarted telithromycin.The patient refused a prescription of cipro due to an upset stomach while taking the previous prescription.On (b)(6) 2018, the patient experienced facial and lip swelling (implant site swelling), throat swelling (pharyngeal oedema), rash (rash), and shortness of breath (dyspnoea).The patient was seen in the emergency room (er) and treated with an epi [epinephrine] injection, h2 blockers [cimetidine], and an unspecified steroid injection.On (b)(6) 2018, the patient requested removal of the product.The physician performed a perioral incision and removed the product without difficulties.A culture was taken and the results were negative.A pathology report showed the presence of "granulamata" material (foreign body reaction).On (b)(6) 2018, it was reported that the patient was happy with the outcome.Outcome at the time of the report: nodules was recovered/resolved.Shortness of breath was recovered/resolved.Swelling was recovered/resolved.Throat swelling was recovered/resolved.Rash was recovered/resolved.Granulamata material was recovered/resolved.Edema was recovered/resolved.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• Type of Device: IMPLANT, 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 Key: 8047438
• MDR Text Key: 126429031
• Report Number: 9710154-2018-00077
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2019
• Device Lot Number: 14959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• 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 Sequence Number: 1
• Treatment: DYSPORT (BOTULINUM)
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR