FDA Adverse Event
Injury
Summary report: N
INCOURAGE SYSTEM
MDR report key: 7673238
·
Received July 10, 2018
Report
- Report Number
- 3004961434-2018-00001
- Event Type
- Injury
- Date Received
- July 10, 2018
- Date of Event
- May 15, 2018
- Report Date
- June 12, 2018
- Manufacturer
- RESPIRATORY TECHNOLOGIES INC.
- Product Code
- BYI
- UDI-DI
- 00841561102785
- PMA / PMN Number
- K051383
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF RECORDS SHOWED NO OTHER SIMILAR REPORTS.
Description of Event or Problem · 1
PATIENT REPORTED BREAST PAIN, WHICH WAS DIAGNOSED AS MASTITIS. ATTENDING PHYSICIAN COULD NOT DETERMINE IF VEST THERAPY WAS THE CAUSE OF THE CONDITION. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION OR COMPLETE AN EVALUATION OF THE DEVICE. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 516948 | INCOURAGE SYSTEM | PULSATING VEST THERAPY | BYI | RESPIRATORY TECHNOLOGIES INC. | ICS-1M-US-A | 00841561102785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |