MAUDE MDR 25341007
- MDR report key
- 25341007
- Report number
- 3003442380-2026-24469
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-03-27
- Date received
- 2026-05-31
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- MS. COURTNEY SMITH
- Address
- AAHOLMVEJ 1 - 3 OSTED LEJRE 4320 DA
- Phone
- 603-603-6032
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 288045 | INSET II | SET, ADMINISTRATION, INTRAVASCULAR | UNOMEDICAL DEVICES S.A DE C.V | FPA | 1002817 | 6017255 | N | N | ||||
| 376674 | INSET II | SET, ADMINISTRATION, INTRAVASCULAR | UNOMEDICAL DEVICES S.A DE C.V | FPA | 1002817 | 6017255 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-05-31 | 0 |
Event Narratives#
No narrative records found.