D
Patient 1
SMS 2400 OVERHEATED DURING REACTION WITH CATALYST. HISSING FROM GAS RELEASE ALSO OCCURRED.
MAUDE MDR 276767
- MDR report key
- 276767
- Report number
- 1059332-2000-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2000-03-17
- Date received
- 2000-05-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 4320 INTERNATIONAL BLVD NORCROSS GA 30093 US
- Phone
- 770-770-7708
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMS 2400 | SHARPS CONTAINER CLASS II | ISOLYSER CO. | MMK | SMS 2400 | * | * | N | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-05-04 | 0 | 1. O |