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

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3 HYALURONIC ACID DERMALL FILLER GEL

  • 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
 

TEOXANE SA TEOSYAL RHA 3 HYALURONIC ACID DERMALL FILLER GEL Back to Search Results
Lot Number TP27L-202323B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Unspecified Vascular Problem (4441); Swelling/ Edema (4577)
Event Date 11/30/2020
Event Type  Injury  
Manufacturer Narrative
Vascular complications are rare serious side effects, although widely known and documented in the context of filler injections. They are related to the accidental injection of the product inside or close to a blood vessel, leading to its occlusion or compression, blocking the blood flow. If treated on time with an appropriate treatment, symptoms can be fully resolved without sequelae. If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis. The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.
 
Event Description
This event happened outside of the us, in (b)(6). According to the received information, the patient was injected with a teosyal rha 3 product (tp27l-192323b) on (b)(6) 2020 in the lips and in the marionette lines. On (b)(6) 2020 the patient experienced symptoms of vascular compromise in the lower lip. She complained of hematoma, pain and swelling localized in the lower lip the practitioner injected 900 ui of hyaluronidase in the affected area on (b)(6) and prescribed drug therapy with: antibiotic (augmentin) for 7 days, oral cortisone (bentelan) for 3 days, fucidin cream to apply to the affected area. According to the latest received information the symptoms completely resolved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTEOSYAL RHA 3
Type of DeviceHYALURONIC ACID DERMALL FILLER GEL
Manufacturer (Section D)
TEOXANE SA
rue de lyon 105
geneva CH 12 03
SZ CH 1203
Manufacturer (Section G)
SAME AS CONTACT OFFICE
same as contact office
Manufacturer Contact
fiona di folco
rue de lyon 105
geneva, CH120-3
SZ   CH1203
MDR Report Key11036249
MDR Text Key222293387
Report Number3005975625-2020-00042
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Lot NumberTP27L-202323B
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
-
-