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

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

Patient Problems Erythema (1840); Occlusion (1984); Pain (1994); Skin Discoloration (2074); Discharge (2225); Discomfort (2330); Numbness (2415); No Code Available (3191)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: lot number was not reported and trending on batch cannot be performed.Pharmacovigilance comment: the serious event of vascular occlusion and the non-serious events of hypoaesthesia, erythema, pain, discomfort, induration, discoloration, wound and discharge were considered expected and possibly related to the treatment.The seriousness criteria included the need for urgent medical intervention in the emergency room, multiple hyaluronidase injections and wound care clinic visits.Potential contributory factors for vascular occlusion include the injection procedure.Potential etiology for the remaining events includes injection site ischemia, and a wound associated with infection or necrosis.The case met the criteria for expedited reporting to regulatory authority.Engineering evaluation: the events are addressed in the labeling.No action is required.(b)(4).

Event Description

(b)(4) is a spontaneous report sent on 12-nov-2017 and a follow-up on 13-nov-2017 by a registered nurse (rn) which refers to a female (b)(6).Medical history, concomitant treatments, and allergies were not reported.The patient had previously received treatment with unspecified restylane products.On (b)(6) 2017, the patient received treatment with an unknown amount of restylane-l (lot unknown) to the nasolabial folds with an unknown needle type and unknown injection technique.On (b)(6) 2017, the patient experienced a vascular occlusion (vascular occlusion).One day later, on (b)(6) 2017, the patient experienced discomfort(injection site discomfort) at the nasolabial fold.On (b)(6) 2017, the patient experienced numbness (implant site hypoaesthesia), pain to touch (implant site pain), hardness(implant site induration) and bluish discoloration (implant site discoloration) at the nasolabial fold.1.5 vials of hyaluronidase[hyaluronidase] was administered to the injection site.On (b)(6) 2017, the patient was seen by the hcp with the same complaints that were improving, but ongoing.A second treatment of 1.5 vials of hyaluronidase was administered.On (b)(6) 2017, the patient experienced redness(implant site erythema) with a wound(wound) that was oozing(injection site discharge) at the nasolabial fold.Treatment for the adverse event included hyaluronidase: 1.5 vials of hyaluronidase on (b)(6) 2017, 1.5 vials of hyaluronidase on (b)(6) 2017 and 1.5 vials of hyaluronidase on (b)(6) 2017.The patient was referred to urgent care, went to the emergency room on (b)(6) 2017 and was referred to a wound care clinic.Outcome at the time of the report: vascular occlusion was not recovered/not resolved.Discomfort was not recovered/not resolved.Numbness was not recovered/not resolved.Pain to touch was not recovered/not resolved.Hardness was not recovered/not resolved.Redness was not recovered/not resolved.Wound was not recovered/not resolved.Oozing was not recovered/not resolved.Bluish discoloration was not recovered/not resolved.

• Brand Name: RESTYLANE-L
• 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 bernaise ; seminarigatan 21; upsala, se-752 28 SE-75-2 28 ; SW SE-752 28
• MDR Report Key: 7041137
• MDR Text Key: 92475333
• Report Number: 9710154-2017-00097
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2017
• Distributor Facility Aware Date: 11/12/2017
• Date Report to Manufacturer: 11/12/2017
• Date Manufacturer Received: 11/12/2017
• 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: 58 YR