FDA Adverse Event
Injury
Summary report: N
M, DREAMWISP NSL
MDR report key: 18483428
·
Received January 10, 2024
Report
- Report Number
- 2518422-2024-01372
- Event Type
- Injury
- Date Received
- January 10, 2024
- Date of Event
- December 11, 2023
- Report Date
- March 7, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- UDI-DI
- 00606959051072
- PMA / PMN Number
- K140980
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 0
DESPITE OF MULTIPLE ATTEMPTS THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. ALL MANDATORY SECTION UPDATED/CORRECTED.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE PATIENT'S DENTIST DETECTED PERIMPLANTITIS AND LOSS OF GUM SUPPORT UP TO 70% IN SOME AREAS. PATIENT DIDN'T SEEK MEDICAL INTERVENTION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2552422 | M, DREAMWISP NSL | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | 1137934 | 00606959051072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |