MAUDE Adverse Event Report: TEOXANE RHA3; RESILIENT HYALURONIC ACID

Lot Number 212518A0

Device Problem Off-Label Use (1494)

Patient Problem Angioedema (4536)

Event Date 02/23/2022

Event Type  Injury  

Event Description

United states report received from other health care professional on 23-feb-2022.A registered nurse (rn) who was also the injector reported that a female patient in her mid-thirties received rha 3 to "even out right side of lip" on (b)(6) 2022.A volume of rha3 0.3 milliliters (ml) was applied to the lips using an unknown injection technique.It is unknown if the needle was used from the box or if a cannula was used for the administration.Previous cosmetic procedures included a past filler use with juvederm to the lips one year ago.Medical history was not provided.Concomitant medications included lisinopril with start date unknown for unknown indication.On (b)(6) 2022, few hours following injection of rha 3, at about 5pm later that evening, the patient woke up from a nap, took a picture and sent it to the injector.From looking at the picture, the injector reported the patient had experienced angioedema.The patient met at the hospital with the injector and was prescribed 25mg decadron, benadryl, and oral steroids.It was unknown if the diagnosis of angioedema was confirmed at the hospital.The outcome of the event was resolving/recovering.The intensity of the event was not provided.It was unknown if the product was available for return.(b)(4).No additional information was available at the time of this report.Case comment: a causal relationship between the rha3 and reported angioedema is assessed as possible based on the compatible temporal relationship and the lack of alternative etiologies that can be identified based on the reported information.Note is made about concomitant lisinopril with an unknown start date and indication.This concomitant medication is known to cause angioedema.

Event Description

Angioedema [angioedema].Rha3 to the lips [off label use].United states report received from a health care professional on 23-feb-2022.A registered nurse (rn) who was also the injector reported that a female patient aged 40 years received rha 3 to "even out right side of lip" on (b)(6) 2022.A volume of rha3 0.3 milliliters (ml) was applied to the lips using an unknown injection technique.It is unknown if the needle was used from the box or if a cannula was used for the administration.Previous cosmetic procedures included a past filler use with juvederm to the lips one year ago, lips filler on an unknown date in 2020; resulted in bad swelling.Medical history included mild hypertension.Concomitant medications included lisinopril with start date unknown to control her mild hypertension.On (b)(6) 2022, few hours following injection of rha3, at about 5pm later that evening, the patient woke up from a nap, took a picture and sent it to the injector.From looking at the picture, the injector reported the patient had experienced angioedema of lips.It was reported that "the patient had a past history of swelling but not to this extent".The patient met at the hospital with the injector and was immediately treated with intravenous (iv) benadryl and 25 mg decadron, and oral steroids for two days.It was unknown if the diagnosis of angioedema was confirmed at the hospital.On an unknown date in 2022, the outcome of the event was completely resolved.The intensity of the event was reported as severe.It was unknown if the product was available for return.Health effect - clinical code: 4536; angioedema.Health effect - device code: 1494, user used incorrect product for intended use.Follow-up information was received on 05-apr-2022 from a rn: updates made to outcome of angioedema, patient's age, added severity, updates to medical history, concomitant and treatment medications.No additional information was available at the time of this report.Case comment: a causal relationship between the rha3 and reported angioedema is assessed as possible based on the compatible temporal relationship and the lack of alternative etiologies that can be identified based on the reported information.Note is made about concomitant lisinopril for hypertension with an unknown start date.This concomitant medication is known to cause angioedema.

• Brand Name: RHA3
• Type of Device: RESILIENT HYALURONIC ACID
• Manufacturer (Section D): TEOXANE; les charmilles; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• MDR Report Key: 13874550
• MDR Text Key: 291244745
• Report Number: 3007772056-2022-00005
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/29/2022,04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 212518A0
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2022
• Distributor Facility Aware Date: 02/23/2022
• Device Age: 0 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LISINOPRIL; LISINOPRIL
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White