FDA Adverse Event
Injury
Summary report: N
EQ-5000 EQUATOR CONVECTIVE WARMER
MDR report key: 1841100
·
Received September 16, 2010
Report
- Report Number
- 2183502-2010-00401
- Event Type
- Injury
- Date Received
- September 16, 2010
- Date of Event
- August 17, 2010
- Report Date
- September 14, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- DWJ
- PMA / PMN Number
- K011907
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGED A PT RECEIVED BURNS ON THE RIGHT SIDE OF THE PT'S RIGHT LEG THAT RESULTED IN SEVERAL SMALL BLISTERS. THE PT WAS RECEIVED TREATMENT FOR THE BLISTERS. THE BLANKET USED DURING THE PROCEDURE WAS DISCARDED. THE HARDWARE IS AVAILABLE FOR EVAL AND WILL BE RETURNED TO THE MANUFACTURER.
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 | UNK | Required Intervention |