D
Patient 1
SMS 10,000 RUPTURED AFTER CATALYST ADDED. DEBRIS REPORTED TO HAVE TRAVELED 20 FEET. UNCONFIRMED BY FIRE DEPT. SKIN AND EYE IRRITATION REPORTED, AGAIN REPORTED BY FIRE DEPT AS TRANSITORY TO PSYCHOSOMATIC.
MAUDE MDR 277757
- MDR report key
- 277757
- Report number
- 1059332-2000-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2000-03-02
- Date received
- 2000-05-11
- 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 10,000 | SHARPS CONTAINER CLASS II | ISOLYSER CO | MMK | SMS 10,000 | * | * | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-05-11 | 0 | 1. H; 2. O |