D
Patient 1
DR (B)(6) CALLED AND SAID THAT ALL HIS HOT PACKS BURST AND ONE GAVE HIS PATIENT A THIRD DEGREE BURN THAT DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION.
MAUDE MDR 2249725
- MDR report key
- 2249725
- Report number
- 1022819-2011-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-08-31
- Date received
- 2011-09-01
- 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
- 1430 DECISION STREET VISTA CA 92081 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CHATTANOOGA | STEAM PACK | DJO GLOBAL | IMG | 1002 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-09-01 | 0 | 1. O |