FDA Adverse Event
Injury
Summary report: N
EQ-5000 EQUATOR CONVECTIVE WARMER
MDR report key: 1490877
·
Received September 21, 2009
Report
- Report Number
- 2183502-2009-00298
- Event Type
- Injury
- Date Received
- September 21, 2009
- Date of Event
- August 6, 2009
- Report Date
- August 13, 2009
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- DWJ
- PMA / PMN Number
- K011907
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL. AS PER DIRECTIONS RECEIVED FROM THE FDA ON 12/9/99. LEVEL I BLANKET WARMING MACHINE; MODEL # EQ 5000-115; CATALOG # UNK.
Description of Event or Problem · 1
PT DEVELOPED A SUNBURNED AREA ON HER LEFT POSTERIOR CALF AND HER LEFT POSTERIOR SIDE FROM A BEAR-HUGGER WARMING BLANKET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EQ-5000 EQUATOR CONVECTIVE WARMER | DWJ - CONVECTIVE WARMER | DWJ | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |