FDA Adverse Event
Injury
Summary report: N
ARTZ DISPO
MDR report key: 2231195
·
Received August 25, 2011
Report
- Report Number
- 9612392-2011-00008
- Event Type
- Injury
- Date Received
- August 25, 2011
- Report Date
- August 25, 2011
- Manufacturer
- SEIKAGAKU CORP.
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE ARE NOW INVESTIGATING THIS CASE.
Description of Event or Problem · 1
ADVERSE EVENT: ARTHRITIS. UNK (DATE) - A (B)(6) PT HAD 1ST ARTZ DISPO INJECTION WITH ROPIVACAINE. ARTHRITIS WITH SWELLING OCCURRED AFTER THE INJECTION. UNK - SHE WAS ADMITTED TO A HOSP. UNK - SHE RECOVERED. ON (B)(6) 2011 AN ORTHOPEDIST AT THE HOSP INQUIRED OF A SALES REP ABOUT ARTHRITIS WITH SWELLING. HE ALSO REPORTED THE PT RECEIVED ARTZ DISPO AT THE OTHER CLINIC HAD ARTHRITIS WITH SWELLING AND WAS ADMITTED TO HIS HOSP. HE CONSIDERED THAT THE EVENT WAS RELATED TO ARTZ DISPO BECAUSE NO INFECTION WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTZ DISPO | ACID, HYALURONIC, INTRAARTICULAR | MOZ | SEIKAGAKU CORP. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization | ANAPEINE INJECTION (ROPIVACAINE) - IR |