FDA Adverse Event
Injury
Summary report: N
INCOURAGE DEVICE
MDR report key: 20100496
·
Received August 29, 2024
Report
- Report Number
- 3004961434-2024-00003
- Event Type
- Injury
- Date Received
- August 29, 2024
- Date of Event
- August 23, 2024
- Report Date
- September 23, 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
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ON (B)(6) 2024, PT REPORTED SHE WAS HAVING DISCOMFORT IN BACK WHILE DOING THERAPY. ON 08/23 PT REPORTED SHE HAS COMPRESSION FRACTURES IN BACK CLINICAL RESOURCE SPECIALIST REVIEWED THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAS A HISTORY OF COMPRESSION FRACTURES. THE PATIENT IS RETURNING THE DEVICE, SHE CANNOT TOLERATE THERAPY.
Description of Event or Problem · 0
ON (B)(6) 2024 THE PATIENT REPORTED SHE WAS HAVING DISCOMFORT IN HER BACK WHILE DOING THERAPY. ON (B)(6) 2024 THE PATIENT REPORTED SHE HAD COMPRESSION FRACTURES IN HER BACK. CLINICAL RESOURCE SPECIALIST REVIEWED THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAS A HISTORY OF COMPRESSION FRACTURES. THE PATIENT IS RETURNING THE DEVICE, SHE CANNOT TOLERATE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1522264 | INCOURAGE DEVICE | PERCUSSOR | BYI | RESPIRATORY TECHNOLOGIES, INC | ICS-1M-US-A | 16616 | 00841561102785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |