MAUDE Adverse Event Report: TEOXANE RHA2; RESILIENT HYALURONIC ACID

Catalog Number 940007

Device Problem Off-Label Use (1494)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Injection Site Reaction (4562)

Event Date 02/07/2021

Event Type  Injury  

Event Description

Allergic symptoms [hypersensitivity].Firm lumps in lips and chin [injection site mass].Rha2 injected into top and bottom lip [off label use].United states report received from a patient on 08-feb-2021.A female patient of unknown age received rha 2 on (b)(6) 2021; dose and frequency were unknown.An unknown volume was applied to the lips and chin using an unknown injection technique and 30-gauge needle supplied from the box.It was not reported whether a cannula was used for administration of rha 2.Previous cosmetic procedures included dermal fillers including juvederm, radiesse kysse, and belotero.Medical history included puffiness following injection of belotero, allergy to penicillin, as well as a previously positive covid-19 diagnosis on an unknown date in (b)(6) 2020.The patient did not receive the covid-19 vaccine.Concomitant medications and food supplements were not provided.On (b)(6) 2021 at 3:00 am, 10 days following the injection of rha 2, the patient experienced an allergic reaction.At 5:00 am, the patient's tongue became swollen.The patient's allergic reaction was further clarified as a swollen lips, face, and jaws.On (b)(6) 2021, the patient then took an unknown amount of benedryl and visited the emergency room, in which she was treated with additional doses of benadryl, prednisone, and iv pepcid.The patient noted there were no gastrointestinal symptoms present.The patient left the emergency room the same day.The patient noted that she had gotten a foster dog the night before on (b)(6) 2021, and has since returned the dog, but stated that her allergic symptoms have persisted.The patient further clarified that the allergic reaction was localized in her face, and that on (b)(6) 2021, 11 days following the injection of rha 2, she stated her chin had become red, lumpy and itchy.On (b)(6) 2021, the patient was injected with hylanex/hyaluronidase to dissolve the filler, but it is unknown in which locations the hyaluronidase was injected.Following the injection of hylanex, the patient still had a couple of firm lumps in her lips (one on the top lip and a couple on the bottom lip).The patient continues to treat with benadryl, although she clarified she is taking less benadryl at the time of this report (5:00 pm on (b)(6) 2021).She stated she has two more dose of prednisone to take.The outcome of the events of allergic reaction was resolving.The outcome of the events of itchy chin and firm lumps on lips was unknown.The intensity of the events was not provided.It was unknown if the product was available for return.(b)(4).No additional information was available at the time of the report.

• Brand Name: RHA2
• 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: 11402066
• MDR Text Key: 234412577
• Report Number: 3007772056-2021-00002
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 02/08/2021

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: 06/12/2023
• Device Catalogue Number: 940007
• Device Lot Number: 202414B0
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other