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.
|
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.
|