FDA Adverse Event
Other
Summary report: N
ORTHOVISC
MDR report key: 2163668
·
Received June 14, 2011
Report
- Report Number
- 1223628-2011-00020
- Event Type
- Other
- Date Received
- June 14, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 14, 2011
- Manufacturer
- ANIKA THERAPEUTICS, INC.
- Product Code
- MOZ
- PMA / PMN Number
- 030019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L IMPLANT DATES: (B)(6) 2010; (B)(6) 2010. THE DEVICE WAS NOT AVAILABLE TO BE RETURNED. ALLERGY CLINIC HAS REQUESTED ANOTHER SAMPLE OF LOT N100071A TO ASSESS IF THE PT WAS ALLERGIC.
Description of Event or Problem · 1
THE PT HAD 3 INJECTIONS OF ORTHOVISC. APPROXIMATELY 2 WEEKS AFTER THE 3RD INJECTION THE PT DEVELOPED HIVES AND AN ANAPHYLACTIC EVENT. THE ALLERGY CLINIC IS TESTING ORTHOVISC WITH HIM TO ASSESS IF THE ORTHOVISC CAUSED THE REACTION. PT HAD BOTH KNEES INJECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOVISC | SODIUM HYALURONATE FOR INTRA-ARTICULAR | MOZ | ANIKA THERAPEUTICS, INC. | 630-254 | N100071A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |