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

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.

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 immediately treated with intravenous benadryl and 25mg decadron, and oral steroids for two days.It was unknown if the diagnosis of angioedema was confirmed at the hospital.The patient was recovering from the event.Final: on 12-apr-2022, we were informed that the patient fully recovered from the event.The corrective treatments were also added.

• Brand Name: TEOSYAL RHA 3
• Type of Device: PATIENT 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 Key: 13860640
• MDR Text Key: 287686960
• Report Number: 3005975625-2022-00100
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 212518A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Race: White