FDA Adverse Event
Injury
Summary report: N
SUPARTZ FX
MDR report key: 7804642
·
Received August 22, 2018
Report
- Report Number
- 9612392-2018-00013
- Event Type
- Injury
- Date Received
- August 22, 2018
- Date of Event
- May 17, 2018
- Report Date
- July 26, 2018
- Manufacturer
- SEIKAGAKU CORPORATION
- Product Code
- MOZ
- PMA / PMN Number
- P980044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
THIS IS A DEFINITIVE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE DESPITE THE FACT THAT MULTIPLE ATTEMPTS TO THE REPORTER HAVE BEEN MADE. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF BIOVENTUS LLC AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2016008.
Description of Event or Problem · 0
(B)(6) 2018 - A (B)(6) YEAR-OLD FEMALE PATIENT RECEIVED SUPARTZ FX INJECTION TO THE BILATERAL KNEES. (B)(6) 2018 - SHE RECEIVED 2ND INJECTIONS. (B)(6) 2018 - SHE RECEIVED 3RD INJECTIONS. (B)(6) 2018 - SHE HAD MULTIPLE HEALTH PROBLEMS AND WAS ADMITTED TO HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647510 | SUPARTZ FX | ACID, HYALURONIC, INTRAARTICULAR | MOZ | SEIKAGAKU CORPORATION | 89130-4444-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization |