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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3 PATIENT RESTRAINT

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TEOXANE SA TEOSYAL RHA 3 PATIENT RESTRAINT Back to Search Results
Model Number NOT APPLICABLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Angioedema (4536)
Event Date 02/23/2022
Event Type  Injury  
Event Description
According to the information received on 24-feb-2022, a patient was injected on (b)(6) 2022 with a rha 3 product, 0. 3ml, to the lips. Later that evening, the patient woke up from a nap, took a picture and sent it to the injector. From looking at the picture, the injector diagnosed an angioedema. The patient met at the hospital with the injector and was prescribed corticoids and antihistaminic. It was unknown if the diagnosis of angioedema was confirmed at the hospital. The patient was recovering from the event.
 
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Brand NameTEOSYAL RHA 3
Type of DevicePATIENT RESTRAINT
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 Key13860640
MDR Text Key287686960
Report Number3005975625-2022-00100
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot Number212518A0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
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: 03/23/2022 Patient Sequence Number: 1
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