FDA Adverse Event
Other
Summary report: N
MIRAGE MICRO MASK SML-AMER
MDR report key: 1613172
·
Received February 12, 2010
Report
- Report Number
- 3004604967-2010-00009
- Event Type
- Other
- Date Received
- February 12, 2010
- Date of Event
- December 29, 2009
- Report Date
- February 12, 2010
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K072940
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A PT REPORTED TO THE DME THAT THEY OBTAINED A "SORE" FROM A NON-RESMED MASK. PT WAS ADVISED TO DISCONTINUE MASK USAGE UNTIL SKIN HEALED. PT CHOSE TO CONTINUE THERAPY USING A RESMED MASK AND THE SORE WORSENED AND BECAME INFECTED. THE PT WAS THEN HOSPITALIZED AND REQUIRED ANTIBIOTICS TO TREAT INFECTION. THE MASK WAS NOT RETURNED TO RESMED AND IS NOT ALLEGED TO HAVE BEEN FAULTY.
Description of Event or Problem · 1
A DME REPORTED A PT USING A CPAP MASK DEVELOPED A BACTERIAL INFECTION THAT REQUIRED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRAGE MICRO MASK SML-AMER | MIRAGE MICRO MASK | BZD | RESMED LTD. | 16333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |