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

Lot Number 19745

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

Patient Problems Hematoma (1884); Necrosis (1971); Skin Discoloration (2074); Ulcer (2274); Pallor (2468); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2022

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 11-apr-2022 by a physician which refers to a female patient of an unknown age.No information about medical history, concomitant medication or history of allergies has been provided.In 2012 (10 years ago), the patient had a chin implant performed on the left side.On (b)(6) 2022, the patient received treatment with restylane lyft lidocaine (lot 19745) to jaw and chin (unknown amount, injection technique and needle type).On 06-apr-2022, it was reported that the patient already exhibited an hematoma (implant site haematoma) at the left lower lip, which was justified by she had been "biting herself".On (b)(6) 2022, the patient's lower lip became purple (implant site discolouration).The patient had contacted the clinic on the same day and after evaluation, the physician injected unknown dose of hyaluronidase [hyaluronidase] as corrective treatment.On (b)(6) 2022, the purple coloration had been improved but the patient experienced a white formation (implant site pallor) inside the mouth, below her lip, for which unspecified antibiotics were prescribed.The patient also experienced crusts (implant site scab) on the right chin where restylane lyft had been injected.On (b)(6) 2022, the patient consulted a dermatologist at another clinic.The patient was informed that she was experiencing a mental lesion constituted by ulceration (implant site ulcer) in the course of the mental artery with intense pain (implant site pain).As corrective treatment, the dermatologist prescribed unspecified antibiotics, pentoxifylline [pentoxifylline], aspirin [acetylsalicylic acid], analgesic and compress.In addition, the patient was requested for hyperbaric chamber.According to the reporting physician, the patient was diagnosed with skin necrosis (implant site necrosis) along the course of the mental artery.Outcome at the time of the report: skin necrosis unknown.Ulceration was unknown.Hematoma was unknown.Lower lip became purple was recovering/resolving.White formation was unknown.Crusts was unknown.Intense pain was unknown.

Manufacturer Narrative

Evaluation text: restylane lyft lidocaine-routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Company comment: the serious events of necrosis and ulcer at implant site, and the non-serious events of haematoma, discolouration, pallor and pain at implant site and scab at injection site were considered expected and possibly related to the treatment.Serious criteria include the need for medical interventions to prevent permanent damage.The potential root cause include intravascular filler injection leading to vascular occlusion and ischemic manifestations.Potential contributory factor include injection technique.The case meets the criteria for expedited reporting to the regulatory authorities.Capa: restylane lyft lidocaine-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 11-apr-2022 by a physician which refers to a female patient of an unknown age.No information about medical history, concomitant medication or history of allergies has been provided.In 2012 (10 years ago), the patient had a chin implant performed on the left side.On (b)(6) 2022, the patient received treatment with restylane lyft lidocaine (lot 19745) to jaw and chin (unknown amount, injection technique and needle type).On (b)(6) 2022, it was reported that the patient already exhibited an hematoma (implant site haematoma) at the left lower lip, which was justified by she had been "biting herself".On (b)(6) 2022, the patient's lower lip became purple (implant site discolouration).The patient had contacted the clinic on the same day and after evaluation, the physician injected unknown dose of hyaluronidase [hyaluronidase] as corrective treatment.On (b)(6) 2022, the purple coloration had been improved but the patient experienced a white formation (implant site pallor) inside the mouth, below her lip, for which unspecified antibiotics were prescribed.The patient also experienced crusts (implant site scab) on the right chin where restylane lyft had been injected.On (b)(6) 2022, the patient consulted a dermatologist at another clinic.The patient was informed that she was experiencing a mental lesion constituted by ulceration (implant site ulcer) in the course of the mental artery with intense pain (implant site pain).As corrective treatment, the dermatologist prescribed unspecified antibiotics, pentoxifylline [pentoxifylline], aspirin [acetylsalicylic acid], analgesic and compress.In addition, the patient was requested for hyperbaric chamber.According to the reporting physician, the patient was diagnosed with skin necrosis (implant site necrosis) along the course of the mental artery.On (b)(6) 2022, the patient was re-evaluated by the reporting physician and there were no lesions on the mentum and on the lip, only a crust that was about to fall off.The reporter had a very different diagnostic impression from a necrosis, which explained the lesions on the lips, where no injection was performed, and the other symptoms.The reporting physician informed that the diagnosis of necrosis cutis was not correct for the case and not even because of the clinical condition, nor the outcome.This diagnosis had been given to the patient by another physician on (b)(6) 2022.As per reporter, a necrosis cutis would recover in a few days without specialized and surgical treatment.Outcome at the time of the report: skin necrosis was recovered/resolved.Ulceration was recovered/resolved.Hematoma was recovered/resolved.Lower lip became purple was recovered/resolved.White formation was recovered/resolved.Crusts was unknown.Intense pain was recovered/resolved.Tracking list: v.0 initial v.1 fu received on 25-apr-2022 from same reporter: outcome of all events except injection site scab and location of event injection site scab were updated.

Manufacturer Narrative

Evaluation text: restylane lyft lidocaine-routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Company comment: the serious events of necrosis and ulcer at implant site, and the non-serious events of haematoma, discolouration, pallor and pain at implant site and scab at injection site were considered expected and possibly related to the treatment.Serious criteria include the need for medical interventions to prevent permanent damage.The potential root cause include intravascular filler injection leading to vascular occlusion and ischemic manifestations.Potential contributory factor include injection technique.Alternative root cause include external compression due to haematoma leading to vascular compromise and ischemic manifestations.The case meets the criteria for expedited reporting to the regulatory authorities.Capa: restylane lyft lidocaine-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

• Brand Name: RESTYLANE LYFT LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 14190350
• MDR Text Key: 293608926
• Report Number: 9710154-2022-00028
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 19745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• 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): Required Intervention
• Patient Sex: Female