FDA Adverse Event
Injury
Summary report: N
MIRAGE ACTIVA LT MASK MED-AMER
MDR report key: 1972241
·
Received January 20, 2011
Report
- Report Number
- 3004604967-2011-00003
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- April 1, 2009
- Report Date
- January 19, 2011
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K032916
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED AND WAS NOT ALLEGED TO BE FAULTY. DENTAL ISSUES ARE A POTENTIAL SIDE EFFECT OF MASK USE AND ARE INCLUDED IN THE "WARNINGS" OF THE ACTIVA LT USER GUIDE: "USING A MASK MAY CAUSE TOOTH, GUM OR JAW SORENESS OR AGGRAVATE AN EXISTING DENTAL CONDITION. IF SYMPTOMS OCCUR, CONSULT YOUR PHYSICIAN OR DENTIST." NOTE: REASON FOR DELAY IN REPORTING. DURING AN INTERNAL AUDIT THAT REVIEWED 3 YEARS OF CLOSED COMPLAINT FILES, THIS COMPLAINT WAS FOUND TO HAVE BEEN AN ISOLATED INCIDENT WHICH WAS INCORRECTLY ASSESSED. RESMED IS SUBMITTING A MEDWATCH NOW AS IT MEETS THE CRITERIA FOR AN MDR REPORTABLE EVENT.
Description of Event or Problem · 1
A PATIENT REPORTED TO THE MANUFACTURER THAT THEIR CPAP MASK WAS CAUSING ALIGNMENT OF THEIR TEETH TO BE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRAGE ACTIVA LT MASK MED-AMER | BZD | RESMED LTD. | 60148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |