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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 4 DERMAL FILLER

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TEOXANE SA TEOSYAL RHA 4 DERMAL FILLER Back to Search Results
Lot Number 213925A0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Infection (4544)
Event Date 03/12/2022
Event Type  Injury  
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Brand NameTEOSYAL RHA 4
Type of DeviceDERMAL FILLER
Manufacturer (Section D)
TEOXANE SA
rue de lyon
105
geneva 1203
CH 1203
Manufacturer (Section G)
TEOXANE SA
rue de lyon
105
geneva 1203
CH 1203
Manufacturer Contact
nicolas caill
rue de lyon
105
geneva 1203
CH   1203
022344-963
MDR Report Key14216753
Report Number3005975625-2022-00170
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
P170002,
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number213925A0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/31/2021
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: 04/27/2022 Patient Sequence Number: 1
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