MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 4; HYALURONIC ACID DERMAL FILLER GEL

Model Number NOT APPLICABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Skin Infection (4544); Injection Site Reaction (4562)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

Skin infections are well known and described adverse reactions following dermal filler injections.They can happen after an injection with an improper technique, inducing a lack of asepsis of the injection environment, which in some case may result in sepsis.External factors, such as the use of makeup immediately after the injection, can also increase the risk of skin infection.Adequate treatment with antibiotics leads to a complete resolution of the symptoms without sequelae.Additionally, the risk of such adverse events is mentioned in the instructions for use of teosyal products.

Event Description

According to the received information, the patient was injected with rha 4 (tpul-202113b) in the mid face on the (b)(6).On the morning of (b)(6) 2020, the patient noticed a red and swollen area under the eye.Throughout the day, the patient noticed that it worsened and progressed from under the eye to the inner corner of the eye near the nose, stretching down towards the mid face.The patient explained that the area was not painful but was red, swollen, and warm to the touch.By 12:00 pm, the under eye started to get slightly puffy and red on the left side.By 8:30 pm, the patient's eye had gotten worse with increased redness and puffiness, so she took 500 mg of pepcid and allerga, but did not see much improvement,.At around 11:00 pm, the patient took another 500 mg of keflex, and saw some improvement.The area was still swollen but was not as red at this time.According to the latest information received on 10-nov-2020, the patient stated that her eye was stiff puffy but not as red.The patient was injected with rha3 and rha4 and experienced the adverse events described in this report and the linked report rc/201147_us_tpul_emdr (mfr report number: 3005975625-2020-00036) to comply with medical device regulatory reporting requirements.

• Brand Name: TEOSYAL RHA 4
• Type of Device: HYALURONIC ACID DERMAL 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 Key: 10957915
• MDR Text Key: 220133030
• Report Number: 3005975625-2020-00037
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/22/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-202113B
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1