FDA Adverse Event
Injury
Summary report: N
MIRAGE SWIFT PILLOW MED
MDR report key: 1619190
·
Received February 26, 2010
Report
- Report Number
- 3004604967-2010-00012
- Event Type
- Injury
- Date Received
- February 26, 2010
- Date of Event
- January 1, 2010
- Report Date
- February 26, 2010
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K042403
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT IS NOT ALLEGED TO BE FAULTY AND WAS NOT RETURNED TO RESMED FOR EVALUATION. THE PATIENT WAS ADVISED BY RESMED'S CLINICAL SUPPORT SPECIALIST TO SEE A PRIMARY CARE PHYSICIAN, SO THAT A PROPER EVALUATION COULD BE PERFORMED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
A PATIENT REPORTED TO RESMED THAT THEIR CPAP MASK WAS CAUSING DEFORMATION OF THEIR SKULL WHERE THE ELASTIC HEADGEAR RESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRAGE SWIFT PILLOW MED | MIRAGE SWIFT | BZD | RESMED LTD. | 60521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |