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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE RHA RESILIENT HYALURONIC ACID

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TEOXANE RHA RESILIENT HYALURONIC ACID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Injection Site Reaction (4562)
Event Type  Injury  
Event Description
Occlusion, progressively gotten worse, vascular occlusion. Swelling, injection site swelling. Crusty, injection site induration. United states report received from a health care professional on 05-apr-2022. A medical assistant reported that an unknown patient received an unspecified rha product on an unknown date in (b)(6) 2022; dose frequency and indication was unknown. An unknown volume of rha injection was applied to the patient using an unknown injection technique. It was unknown if the needle was used from the box or if a cannula was used for the rha application. Previous cosmetic procedures were not provided. Medical history was not provided. Concomitant medications and food supplements were not provided. On an unknown date in (b)(6) 2022, the patient was injected with an unknown rha product. After unspecified duration, the patient experienced an "occlusion" further described as a little swollen and crusty. As a treatment included putting the patient under a red light for the swelling. At the time of this report, the patient had not recovered from the events. The intensity of the events was not provided. It is unknown if the product was available for return. Teoxane rma number: (b)(4). No additional information was available at the time of this report. Case comment: a causal relationship between reported vascular occlusion and rha 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 that this report contains a very limited information including rha injection site and volume, the signs and symptoms described were not typical for vascular occlusion. Note is also made that the patient was not treated for vascular occlusion at the time of reporting. The company will continue monitoring the benefit-risk profile for the product.
 
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Brand NameRHA
Type of DeviceRESILIENT HYALURONIC ACID
Manufacturer (Section D)
TEOXANE
les charmilles
rue de lyon, 105
geneva, CH-12 03
SZ CH-1203
MDR Report Key14251333
MDR Text Key290448845
Report Number3007772056-2022-00008
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 Other Health Care Professional
Type of Report Initial
Report Date 04/29/2022,04/05/2022
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/29/2022
Distributor Facility Aware Date04/05/2022
Device Age0 YR
Was Device Evaluated by Manufacturer? No Answer Provided

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