FDA Adverse Event
Injury
Summary report: N
ARTZ DISPO
MDR report key: 1612186
·
Received February 17, 2010
Report
- Report Number
- 9612392-2010-00002
- Event Type
- Injury
- Date Received
- February 17, 2010
- Date of Event
- January 1, 2007
- Report Date
- February 17, 2010
- Manufacturer
- SEIKAGAKU CORP
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE ARE NOW INVESTIGATING THIS CASE. EXPIRATION DATE : JULY 2010.
Description of Event or Problem · 1
ADVERSE EVENT: SWELLING, PAIN. ON (B) (6) 2007 - A PT RECEIVED ARTZ DISPO INJECTION INTO THE KNEE FOR OSTEOARTHRITIS. IN 2007 - THE PT EXPERIENCED DISCOMFORT OF LEG, FINALLY HE/SHE WAS NOT ABLE TO MOVE LEG SMOOTHLY. UNK - THE PT WAS ADMITTED TO ANOTHER HOSPITAL. THE PHYSICIAN CONSIDERED THE PT'S COMPLAINT IS UNREASONABLE, SO HE REQUESTED INFORMATION ABOUT ARTZ DISPO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTZ DISPO | SODIUM HYALURONATE | MOZ | SEIKAGAKU CORP | NA | 6X644Z OR ZB726Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | TRADE NAME (GENERIC NAME) - ROUTE OF ADMIN -| DAILY DOSE - INITIAL DATE AND FINAL DATE OF ADMIN |