MAUDE MDR 8781310
- MDR report key
- 8781310
- Report number
- 2432235-2019-00235
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-06-17
- Date received
- 2019-07-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. MIR KHAN
- Address
- 511 BENEDICT AVENUE TARRYTOWN NY 10591 US
- Phone
- 914-914-9145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2000 XPI - SPE | IMMULITE 2000 XPI - SPE | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED | DHB | IMMULITE 2000 XPI - SPE | F17L4 | 603 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-07-11 | 0 |
Event Narratives#
No narrative records found.