MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for GEL-ONE 30MG/3ML SYR manufactured by Seikagaku Corporation Takanagi Plant.
[184055536]
Patient reported that she was hospitalized due to heart attack and now has medications. Md: (b)(6); manufacturer name: zimmer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093733 |
| MDR Report Key | 9829237 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-01 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEL-ONE 30MG/3ML SYR |
| Generic Name | ACID, HYALURONIC, INTRAARTICULAR |
| Product Code | MOZ |
| Date Received | 2020-03-12 |
| Lot Number | 0019H08G |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEIKAGAKU CORPORATION TAKANAGI PLANT |
| Product Code | --- |
| Date Received | 2020-03-12 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-12 |