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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE RHA4 RESILIENT HYALURONIC ACID

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TEOXANE RHA4 RESILIENT HYALURONIC ACID Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problems Obstruction/Occlusion (2422); Injection Site Reaction (4562)
Event Type  Injury  
Event Description
Suspected vascular occlusion [vascular occlusion]. Bruise [injection site bruising]. Rha4 to the lower face, mental crease and chin area [off label use]. United states report received from a healthcare professional on (b)(6) 2022. A nurse practitioner who was also the prescriber and injector reported that a female patient of unknown age received a follow-up dose of rha4 for mental crease, on (b)(6) 2022; dose and frequency were not reported. An unknown volume of rha4 injection was applied to the lower face, chin area and mental crease using an unknown injection technique. The needle was used from the box. A cannula was not used for the administration of the rha4 product. Previous cosmetic procedures were not provided. Medical history was not provided. Concomitant medications, and food supplements were not provided. On (b)(6) 2022, during an evaluation, a patient was injected with an unknown amount of rha 4 to the lower face, mental crease, and chin area, immediately following the injection, a bruise developed very quickly. On an unknown date, the prescriber suspected the patient experienced a vascular occlusion. As a treatment the patient had aspirin, heat compress, massage, dissolving the filler with hyaluronidase, and lidocaine without epi to help numb the area. The outcome of the events was resolved. The product was not available for return. (b)(4). No additional information was available at the time of this report. Case comment: a causal relationship between the reported vascular occlusion and rha4 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. The company will continue monitoring the benefit-risk profile for the product.
 
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Brand NameRHA4
Type of DeviceRESILIENT HYALURONIC ACID
Manufacturer (Section D)
TEOXANE
les charmilles
rue de lyon, 105
geneva, CH-12 03
SZ CH-1203
MDR Report Key14251247
MDR Text Key290391722
Report Number3007772056-2022-00007
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 04/29/2022,04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/29/2022
Distributor Facility Aware Date04/04/2022
Device Age0 YR
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
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