FDA Adverse Event
Death
Summary report: N
GEL-ONE
MDR report key: 4921998
·
Received July 3, 2015
Report
- Report Number
- 9612392-2015-00011
- Event Type
- Death
- Date Received
- July 3, 2015
- Report Date
- June 9, 2015
- Manufacturer
- SEIKAGAKU CORPORATION
- Product Code
- MOZ
- PMA / PMN Number
- P080020
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEIKAGAKU CORPORATION REQUESTED (B)(4) TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE SPOUSE FOR ALL THEIR FREQUENT CONTACTS. REF (B)(4).
Additional Manufacturer Narrative · 1
SEIKAGAKU CORPORATION WAS REQUESTING ZIMMER, INC., TO GATHER ADD'L INFO. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC., AS THE IMPROPER WITH AUTHORIZATION BY THE EXEMPTION NUMBER (B)(4).
Description of Event or Problem · 1
UNK - APPROX 60 Y/O MALE PT RECEIVED GEL-ONE INJECTION TO THE LEFT KNEE FOR OSTEOARTHROSIS. UNK - HIS WIFE REPORTED THE PT DIED. NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434007 | GEL-ONE | ACID, HYALURONIC, INTRAARTICULAR | MOZ | SEIKAGAKU CORPORATION | 00-1111-001 | 0013G24G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |