FDA Adverse Event
Injury
Summary report: N
VEST MODEL 105
MDR report key: 2162319
·
Received July 8, 2011
Report
- Report Number
- 1045510-2011-00023
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- May 19, 2011
- Report Date
- June 8, 2011
- Manufacturer
- HILL-ROM SERVICES PRIVATE LIMITED
- Product Code
- BYI
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT ALLEGING THAT THE PATIENT'S RIB DISLOCATED AFTER VEST TREATMENT. THE PATIENT INDICATED THAT THE RIBS WOULD HEAL ON THEIR OWN, AND LATER STATED THAT THE RIBS HAVE PROBABLY HEALED BY NOW. THE UNIT WAS RETURNED AND EVALUATED - NO MALFUNCTION WAS ALLEGED NOR FOUND THROUGH THE ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VEST MODEL 105 | POWERED PERCUSSOR | BYI | HILL-ROM SERVICES PRIVATE LIMITED | 105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |