FDA Adverse Event
Injury
Summary report: N
AFFLOVEST
MDR report key: 8178717
·
Received December 19, 2018
Report
- Report Number
- 1645362-2018-00005
- Event Type
- Injury
- Date Received
- December 19, 2018
- Date of Event
- October 20, 2018
- Report Date
- November 26, 2018
- Manufacturer
- INTERNATIONAL BIOPHYSICS CORPORATION
- Product Code
- BYI
- UDI-DI
- 00814321020056
- PMA / PMN Number
- K122480
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT'S UNDERLYING PATHOLOGY AND MEDICATION MAY HAVE CONTRIBUTED TO THE FRACTURED RIBS. THE PATIENT DID NOT ALLEGE THE DEVICE MALFUNCTIONED. THE DEVICE WAS RETURNED TO IBC FOR INVESTIGATION, AND THE DEVICE MET ALL ACCEPTANCE CRITERIA.
Description of Event or Problem · 1
RESPIRATORY THERAPIST WAS INFORMED THAT THE USER SUFFERED SEVERAL BROKEN RIBS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1019752 | AFFLOVEST | IBC HFCWO VIBRATORY VEST | BYI | INTERNATIONAL BIOPHYSICS CORPORATION | 8200 | 090618-6642 | 00814321020056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization |