• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Lot Number (10)202113BO
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Inflammation (1932); Swelling/ Edema (4577)
Event Date 11/09/2020
Event Type  Injury  
Event Description
United states report received from a nurse, who is also the patient, via consultant on 9-nov-2020. An adult female patient (age unknown) received rha4 on (b)(6) 2020 in order to treat dynamic folds and wrinkles during a singular session. Dose was not reported. The patient was injected with half a syringe of rha4 in the bilateral nasolabial folds and lateral malar cheek area of the face, using a linear threading, fanning technique. A total of two, 1. 5 syringes were used. Volume was not reported. It was not reported whether a cannula was used for administration. Previous cosmetic procedures were unknown/not provided. Medical history included administration of xeomin (incobotulinumtoxina). Concomitant medications and food supplements were not provided. On the morning of (b)(6) 2020, 4 days following injection of rha4, the patient noticed a red and swollen area under the eye, which was clarified as right tear trough swelling at least one inch away from the injection site. Swelling was also noted in the right upper eyelid. The swelling was erythematous and warm, but was not painful nor was it accompanied by fever, chills or systemic signs of infection. This was clarified by the nurse practitioner to likely be an inflammatory reaction. By 8:00 pm on (b)(6) 2020, the patient noticed increased unilateral swelling around her right eye and she self-administered keflex (cefalexin) 500 milligram (mg) and allegra (fexofenadine). At bedtime on (b)(6) 2020, the swelling intensified further and she took an additional dose of keflex 500 mg. In the morning on(b)(6) 2020, because of persistent swelling, the patient took an additional dose of keflex 500 mg and an additional fexofenadine and started a solu-medrol dose pack (methylprednisolone). By (b)(6) 2020, the swelling was much improved and the erythema and warmth had disappeared. The patient continued tapering her glucocorticoid and continued on daily fexofenadine. She treated the remaining swelling with self-massage. The swelling continued to improve and as (b)(6) 2020, the swelling is reported to be at least 90% resolved. The patient did not believe she had an injection site infection. Instead she believed she had an inflammatory reaction responsive to glucocorticoid. The patient planned to continue to monitor her progress. The outcome of the events was resolving. The product was not available for return. (b)(4). This case is linked to (b)(4) (same patient). The patient was injected with rha3 and rha4 and experienced the adverse events described in this report and the linked report(s) to comply with medical device regulatory reporting requirements. No additional information was available at the time of the report.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRHA4
Manufacturer (Section D)
les charmilles
rue de lyon, 105
geneva, CH-12 03
SZ CH-1203
MDR Report Key10979407
MDR Text Key220643051
Report Number3007772056-2020-00005
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date 12/09/2020,11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number(10)202113BO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2020
Distributor Facility Aware Date11/09/2020
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/09/2020 Patient Sequence Number: 1