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

Lot Number TPUL-194111B

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Granuloma (1876); Skin Infection (4544); Injection Site Reaction (4562)

Event Type  Injury  

Manufacturer Narrative

Granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells (macrophages) forming a more or less hard and inflammatory mass.A treatment with hyaluronidase and anti-inflammatories generally allows to treat these reactions quickly and effectively, although certain granulomas at an advanced stage might be unresponsive to hyaluronidase.The risk of such reaction is mentioned in the instructions for use of teosyal products.Biofilms are well-known and documented side effects in hyaluronic acid filler injections.The gel is surrounded by common skin colonizing bacteria that irreversibly adhere to the gel inducing a permanent immune response.When conditions are favourable (infectious disease, trauma, ), this may eventually lead to a chronic granulomatous reaction.Given the sterility of the gel, they are rather due to a defect in the aseptic environment of the injection.Appropriate treatment allows progressive resolution of the symptoms.The risk of such reactions is mentioned in the instructions for use of teosyal products.

Event Description

According to the received information, the patient was injected in the lips with a teosyal rha 4 product on the (b)(6).Approximately three weeks following the administration of rha4, the patient developed bumps, white lumps, and granulomas throughout her entire mouth and on both lips.On (b)(6) 2020, the patient returned to the physician's office and as treatment, received 0.1 ml of hyaluronidase into both lips.On an unknown date, the patient reported no improvement and was diagnosed with biofilm and granulomas.On (b)(6) 2020, the patient returned to the physician's office and as treatment received a steroid and antibiotic; 0.5 ml of hylenex 75 units, 125 milligrams (mg) augmentin by mouth and 10 mg of prednisone by mouth.The patient was told to massage the lips for the rest of the day to help break down the lumps.On (b)(6) 2020, the patient returned to the physician's office and as treatment received an additional 30 units of hylenex into her lips.The physician attempted to extract the granuloma and filler.On an unknown date, the patient stated that the filler was blowing up.On (b)(6) 2020, the patient returned to the physician's office and was advised to continue the antibiotics.An additional 75 units of hylenx were administered on (b)(6) 2020.On unknown date, prednisone was discontinued due to heart palpitations.On (b)(6) 2020, the patient sought a second opinion from an unknown physician and stated that the physician advised the lips would need to be injected with hyaluronidase.On (b)(6) 2020, the patient stated that she was a little puffy but was in no pain.She was on doxy, 100 mg bid, as treatment.The outcome of the events was not resolved.(b)(4).No additional information was available at the time of this report.

• Brand Name: 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: 11009999
• MDR Text Key: 221731617
• Report Number: 3005975625-2020-00040
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/07/2022
• Device Lot Number: TPUL-194111B
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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