MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for GEL-ONE X-LINKED HYALUR 3ML 00111100100 manufactured by Seikagaku Corporation.
[181934915]
It was reported by the patient that post-injection at doctor's office, she fainted, developed a severe itch and rash and experienced chest pain. The patient was hospitalized for two days and discharged with benadryl. No additional patient consequences were reported at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00820 |
| MDR Report Key | 9785331 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-03 |
| Date Facility Aware | 2020-02-28 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Added to Maude | 2020-03-04 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEL-ONE X-LINKED HYALUR 3ML |
| Generic Name | BIOLOGICS |
| Product Code | MOZ |
| Date Received | 2020-03-04 |
| Catalog Number | 00111100100 |
| Lot Number | UNK |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-04 |