FDA Adverse Event
Injury
Summary report: N
SYNVISC ONE
MDR report key: 4916365
·
Received July 9, 2015
Report
- Report Number
- MW5044176
- Event Type
- Injury
- Date Received
- July 9, 2015
- Date of Event
- July 7, 2015
- Report Date
- July 8, 2015
- Manufacturer
- GENZYME
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT DOES NOT WANT SYNVISC ONE FILLED BECAUSE INSURANCE WON'T COVER AND HE FELT MEDICATION WAS INEFFECTIVE THE LAST TIME HE RECEIVED IT. AMOUNT: 48 MG; FREQUENCY: "G6#" MONTHS; ROUTE: INTRA-ARTICULARLY. DATE OF USED: 06/2015 TO UNKNOWN. REASON FOR USE: OSTEOARTHRITIS OF THE KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 444822 | SYNVISC ONE | SYNVISC ONE, 48 MG/6 ML | MOZ | GENZYME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | NOT PROVIDED |