FDA Adverse Event
Injury
Summary report: N
INCOURAGE DEVICE
MDR report key: 17921949
·
Received October 12, 2023
Report
- Report Number
- 3004961434-2023-00004
- Event Type
- Injury
- Date Received
- October 12, 2023
- Date of Event
- September 15, 2023
- Report Date
- May 23, 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
CORRECTED DATA. SERIAL NUMBER ON INITIAL AND FOLLOW-UP REPORT WAS INCORRECT.
Additional Manufacturer Narrative · 0
THE PATIENTS PRIMARY CARE PROVIDER ADVISED THE PATIENT TO DISCONTINUE USE OF THE DEVICE. THE DEVICE IS PAID IN FULL, PATIENT OWNED DEVICES ARE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 0
THIS IS A FOLLOW-UP REPORT TO CORRECT THE SERIAL NUMBER IN THE INITIAL AND FOLLOW-UP REPORTS.
Description of Event or Problem · 0
THE PATIENT HAS KIDNEY ISSUES AND IS WONDERING IF THE DEVICE COULD HAVE CAUSED HER ISSUES.
Description of Event or Problem · 0
THE ADVISED SHE HAS KIDNEY ISSUES AND IS WONDERING IF THE DEVICE CAUSED HER ISSUES. SHE STATED SHE IS NEEDING A KIDNEY TRANSPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2119272 | INCOURAGE DEVICE | PERCUSSOR, POWERED-ELECTRIC, PRODUCT CODE: BYI | BYI | RESPIRATORY TECHNOLOGIES, INC | R500055-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |