FDA Adverse Event
Injury
Summary report: N
REVANESSE VERSA+ 1.2 ML
MDR report key: 17113338
·
Received June 12, 2023
Report
- Report Number
- 3004423487-2023-00022
- Event Type
- Injury
- Date Received
- June 12, 2023
- Date of Event
- April 19, 2023
- Report Date
- June 12, 2023
- Manufacturer
- PROLLENIUM MEDICAL TECHNOLOGIES INC
- Product Code
- LMH
- UDI-DI
- 10669808001038
- PMA / PMN Number
- P160042 S004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ON (B)(6) 2023, A PATIENT WAS INJECTED WITH 0.4 ML OF LOT 22L122, REVANESSE VERSA+ HA FILLER INTO THEIR UNDEREYE AREA. PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONTACTED THE CLINIC FOUR TIMES VIA EMAIL AND PHONE (11-MAY-2023 18-MAY-2023, 24-MAY-2023, 12-JUN-2023) TO OBTAIN ADDITIONAL INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT. THE CLINIC DID NOT RESPOND. PROLLENIUM MEDICAL TECHNOLOGIES INC. WILL CONTINUE THE INVESTIGATION. INTERNAL REPORT NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1010541 | REVANESSE VERSA+ 1.2 ML | REVANESSE VERSA+ | LMH | PROLLENIUM MEDICAL TECHNOLOGIES INC | 40083 | 22L122 | 10669808001038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female |