FDA Adverse Event
Injury
Summary report: N
INCOURAGE DEVICE
MDR report key: 18507633
·
Received January 12, 2024
Report
- Report Number
- 3004961434-2024-00001
- Event Type
- Injury
- Date Received
- January 12, 2024
- Date of Event
- December 14, 2023
- Report Date
- June 7, 2024
- Manufacturer
- RESPIRATORY TECHNOLOGIES, INC
- Product Code
- BYI
- PMA / PMN Number
- K051383
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER BECAUSE THE DEVICE WAS PAID IN FULL. THE CUSTOMER OWNS THE DEVICE.
Description of Event or Problem · 0
THE PATIENT WENT INTO THE ER FOR HORRIFIC PAIN. DIAGNOSED WITH ENLARGED SPLEEN AND IS CONCERNED THE SPLEEN IS BECOMING RUPTURED. THE PATIENT ASKED IF THEY COULD USE THE VEST MORE OFTEN, BUT SINCE THE PAIN HAS BECOME WORSE. THE PATIENT IS CONCERNED THAT THE VEST MAY BE CAUSING IT.
Description of Event or Problem · 0
THE PATIENT WENT INTO THE ER FOR HORRIFIC PAIN. DIAGNOSED WITH ENLARGED SPLEEN AND IS CONCERNED THE SPLEEN IS BECOMING RUPTURED. THE PATIENT ASKED IF THEY COULD USE THE VEST MORE OFTEN, BUT SINCE THEN THE PAIN HAS BECOME WORSE. THE PATIENT IS CONCERNED THAT THE VEST MAY BE CAUSING IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2002796 | INCOURAGE DEVICE | PERCUSSOR, POWERED-ELECTRIC | BYI | RESPIRATORY TECHNOLOGIES, INC | R500055-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |