FDA Adverse Event
Injury
Summary report: N
ARTZ DISPO
MDR report key: 3984612
·
Received August 6, 2014
Report
- Report Number
- 9612392-2014-00009
- Event Type
- Injury
- Date Received
- August 6, 2014
- Date of Event
- June 26, 2014
- Report Date
- July 9, 2014
- Manufacturer
- SEIKAGAKU CORP.,
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE ARE UNDER INVESTIGATION IN DETAILS.
Description of Event or Problem · 1
ON (B)(6) 2014, A (B)(6) FEMALE PATIENT RECEIVED 1ST INJECTION OF ARTS DISPO FOR ROTATOR CUFF INJURY IN THE LEFT SHOULDER JOINT. IMMEDIATELY AFTER THE INJECTION, SHOULDER PAIN DEVELOPED. AT THE NIGHT, SHE FELT A CHILL AND HAD FEVER OF 39 DEGREES C. ON (B)(6) 2014, SHE VISITED THE INJECTION PHYSICIAN AND WAS ADMITTED TO THE HOSPITAL WITH THE PURPOSE OF OBSERVATION. NO FLUID WAS RETAINED. NO PUS-FILLED SPACE WAS FOUND IN HER MEDICAL IMAGE. NSAID WAS PRESCRIBED. ON (B)(6) 2014, HER FEVER SUBSIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459161 | ARTZ DISPO | ACID, HYALURONIC, INTRAARTICUALR | MOZ | SEIKAGAKU CORP., | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization | LOXONIN TABLET 60MG| MUCOSTA TABLET 100MG| VOLTAREN TAPE 15MG| THIURAGYL TABLET 50 MG |