FDA Adverse Event
Death
Summary report: N
ORTHOVISC (2ML/SYR)
MDR report key: 12384298
·
Received August 27, 2021
Report
- Report Number
- MW5103548
- Event Type
- Death
- Date Received
- August 27, 2021
- Date of Event
- May 15, 2021
- Report Date
- August 25, 2021
- Manufacturer
- JANSSEN PRODUCTS / ANIKA THERAPEUTICS, INC.
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PER PATIENT'S SPOUSE (B)(6), PATIENT HAS PASSED AWAY AS OF (B)(6) 2021. THE DEATH CERTIFICATE WAS INCLUDED. NO FURTHER INFORMATION PROVIDED INDICATION: BILATERAL POST-TRAUMATIC OSTEOARTHRITIS OF KNEE SPONTANEOUS CALL. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1277871 | ORTHOVISC (2ML/SYR) | ACID, HYALURONIC, INTRAARTICULAR | MOZ | JANSSEN PRODUCTS / ANIKA THERAPEUTICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death |