FDA Adverse Event
Injury
Summary report: N
HYALGAN
MDR report key: 235072
·
Received March 26, 1999
Report
- Report Number
- MW1016933
- Event Type
- Injury
- Date Received
- March 26, 1999
- Date of Event
- January 11, 1999
- Report Date
- March 26, 1999
- Manufacturer
- FIDIA PHARMACEUTICAL CORP.
- Product Code
- LZX
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AN ORTHOLOGICS REP REPORTED THAT A CONSUMER HAD AN "INJECTION SITE REACTION" WHICH REQUIRED SUBSEQUENT HOSPITALIZATION AND TREATMENT WITH IV ANTIBIOTICS. CORRECTIVE TREATMENT: IV ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYALGAN | INTRA-ARTICULAR INJECTION | LZX | FIDIA PHARMACEUTICAL CORP. | NI | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |