RHA® 4 Mepi RHA® 4 Mepi - TSK - USRecalls & reported problems
Teoxane SA · "One box of RHA® 4 Mepi contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233411) is defined as unit of sales and identified with a serial number." · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640173233480), received between Sep 24, 2026 and Sep 24, 2026 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abscess1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Abscess / discharged purulent material / Pustula formed over area "[Abscess]".RHA 4 in the chin "[Off label use]". A trauma caused tenderness and pain "[Pain]". Case Narrative: On 26-Aug-2026, PrimeVigilance from USA notified Teoxane Geneva of an adverse event. The case was reported by the injector.According to the reporter, a female patient was injected on (b)(6) 2026 with 1 syringe of RHA 4 in the chin using a needle and a needle-to-bone injection technique.The patient had a history of previous aesthetic procedures in the chin performed by another injector:Restylane Defyne on (b)(6) 2025,Restylane Lyft on (b)(6) 2025,RHA 4 on (b)(6) 2025,Relevant medical history included a treatment with an immunosuppressant. Around (b)(6) 2026, the patient had a trauma to the chin after being headbutted by a child, resulting in tenderness and pain in the area. On (b)(6) 2026, the patient received two Hyaluronidase treatments to dissolve the filler (reason why not provided). At this time, an abscess was noticed by the injector, and an antibiotherapy was prescribed. According to the injector, it remained unclear whether the trauma triggered the subsequent abscess.On (b)(6) 2026, a pustule appeared
Patient problems: Abscess
MAUDE report 50880062 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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