FDA Adverse Event
Injury
Summary report: N
INCOURAGE
MDR report key: 20272855
·
Received September 20, 2024
Report
- Report Number
- 3004961434-2024-00004
- Event Type
- Injury
- Date Received
- September 20, 2024
- Date of Event
- August 21, 2024
- Report Date
- September 20, 2024
- Manufacturer
- RESPIRATORY TECHNOLOGIES, INC
- Product Code
- BYI
- UDI-DI
- 00841561102785
- PMA / PMN Number
- K051383
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE PATIENT STATED: I USE NEBULIZER AT THE SAME TIME AS THE VEST. I CANNOT TELL WHICH ONE HELPS ME MORE. I HAVE NOT USED THE VEST FOR ABOUT A WEEK DUE TO RIB SEPARATION. I SHOULD START BACK IN 2 WEEKS. I WAS USING 1X PER DAY FOR 30 MINUTES AT 55% PRESSURE. OUTCOMES SPOKE WITH THE PATIENT'S DAUGHTER WHO ADVISED THAT THE PATIENT WILL NOT USE THERAPY AS HE SAID IT IS NOT BENEFITING HIM AND FEELS IT CAUSED HIS RIB PAIN. OS ADVISED ABOUT REDUCING TIME AND PRESSURE, BUT SHE SAID THE PATIENT WAS FIRM IN THE DECISION TO RETURN AND THAT HIS HCT SAID HE COULD DISCONTINUE THERAPY. THE DEVICE WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1668476 | INCOURAGE | PERCUSSOR | BYI | RESPIRATORY TECHNOLOGIES, INC | ICS-1M-US-A | 15708 | 00841561102785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |