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

Lot Number S2173390003

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

Patient Problems Embolism (1829); Unspecified Infection (1930); Necrosis (1971)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Pharmacovigilance comments: the serious events of embolism, skin necrosis and infection were considered expected and possibly related to the treatment.Serious criteria included the need for unspecified medical or surgical intervention.Potential contributory factors include injection technique.The 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.Manufacturing narrative: the reported lot number s22173390003 is not valid (eleven digits instead of ten).The lot number sequence and the expiry date 12-dec-2019 suggested that the suspected product was restylane refyne with lot number s2173390003.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to symatese quality management system.

Event Description

Case reference number (b)(4) is a spontaneous report received on (b)(6) 2018 via e-mail from (b)(6) which was reported to them by a physician.The case concerns a patient of unknown age and gender.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2018, the patient received treatment with restylane refyne (lot number s2173390003, expiry date 31-dec-2019) to an unknown location.The amount of volume used, injection technique and needle type were unknown.The same day, on (b)(6) 2018 the patient developed embolism (embolism) and thereof skin necrosis (skin necrosis) and secondary infection (infection) at an unknown location.On an unknown date, the patient received unspecified medical or surgical intervention.Outcome at the time of the report: skin necrosis was unknown.Secondary infection was unknown.Embolism was unknown.

• Brand Name: RESTYLANE REFYNE
• 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: 7973754
• MDR Text Key: 123971801
• Report Number: 9710154-2018-00061
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P140029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2018

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Lot Number: S2173390003
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/17/2018
• Date Device Manufactured: 01/01/2018
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention