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

Lot Number 17943

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

Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious expected event of infection at implant site was considered possibly related to the treatment.Serious criteria include the need for multiple medical, surgical interventions and hospitalization.The non-serious expected events of warmth, swelling and mass at implant site were considered possibly related to the treatment.The potential route causes for the events include user error of breach in aseptic technique or microbial contamination of the device.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.Manufacturer narrative: the reported lot number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 09-dec-2020 by an other health professional which refers to a (b)(6)-year-old female patient.Initial invalid report from a same reporter was received on 21-jul-2020.It was mentioned that a patient in tasmania presented with infection post treatment of an unknown product.Three follow-up attempts were completed and sent to reporter on 22-jul-2020, 03-aug-2020 and 04-aug-2020, all without success.As per information received on 09-dec-2020, product was updated to restylane lidocaine and the report was considered valid.The patient had fitzpatrick skin type iii.The patient's medical history included allergy to penicillin and cephalexin.The patient was not taking any concomitant medications routinely.The patient had previously received treatment with belotero shape and contour on (b)(6) 2019 to lips and top lip lines.On (b)(6) 2020, the patient received treatment with 1 ml restylane lidocaine (lot 17943) to nasolabial area folds, lines (0.3 ml each side) and lips (upper lip 0.1 ml each side, lower lip 0.1 ml each side) for volume defect using linear thread technique with unknown needle type.12 days later, on (b)(6) 2020, the patient experienced hot(implant site warmth), swollen(implant site swelling) and lump(implant site mass) on the left nasolabial area.Unknown time later, on an unknown date in 2020, the patient experienced infection(implant site infection).The patient received treatment with clarithromycin [clarithromycin] 500 mg bd from (b)(6) 2020 to (b)(6) 2020 and reported that the infection persisted, the patient received ciprofloxacin [ciprofloxacin] 500 mg bd from (b)(6) 2020 to an unknown date in 2020 and treatment result was reported as worsening after 1 week.On (b)(6) 2020, the patient was injected with 30 u of hyalase [hyaluronidase].On an unknown date in 2020, the patient was hospitalized for scan and drainage (unsure of hospitalization).The patient had another 3 weeks of clindamycin [clindamycin], ciprofloxacin and the lesion has resolved now.The antibiotics were stopped.The reporter has not provided a complete seriousness assessment.Outcome at the time of the report: infection was recovered/resolved.Hot was recovered/resolved.Swollen was recovered/resolved.Lump was recovered/resolved.

• Brand Name: RESTYLANE LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 11065981
• MDR Text Key: 223424098
• Report Number: 9710154-2020-00103
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P040024/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 17943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR