MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for GEL-ONE X-LINKED HYALUR 3ML 00111100100 manufactured by Seikagaku Corporation.
[182572653]
It was reported that the patient received a gel-one injection on an unknown date. Subsequently, the patient is experiencing hives and swelling. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00678 |
| MDR Report Key | 9744926 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date Facility Aware | 2020-01-30 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEL-ONE X-LINKED HYALUR 3ML |
| Generic Name | BIOLOGICS |
| Product Code | MOZ |
| Date Received | 2020-02-24 |
| Catalog Number | 00111100100 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEIKAGAKU CORPORATION |
| Manufacturer Address | 6-1, MARUNOUCHI 1-CHROME CHIYODA-KU, TOKYO 100-0005 JA 100-0005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |