FDA Adverse Event
Injury
Summary report: N
GEL-ONE
MDR report key: 4291224
·
Received October 27, 2014
Report
- Report Number
- 9612392-2014-00019
- Event Type
- Injury
- Date Received
- October 27, 2014
- Manufacturer
- SEIKAGAKU CORP.
- Product Code
- MOZ
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A DEFINITIVE REPORT. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER # (B)(4).
Description of Event or Problem · 1
PLEASE REFER TO IMPORTER REPORT #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 684024 | GEL-ONE | ACID, HYALURONIC, INTRAARTICULAR | MOZ | SEIKAGAKU CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |