FDA Adverse Event
Injury
Summary report: N
9XT SWINGAWAY FRAME STYLE 9153629153
MDR report key: 4811630
·
Received June 2, 2015
Report
- Report Number
- 9616091-2015-01320
- Event Type
- Injury
- Date Received
- June 2, 2015
- Report Date
- May 6, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - 5/11/2015 - SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
END USER STATES THE 9XT CHAIR HE IS IN HAS A 1 INCH DUMP IN THE BACK. HE IS CLAIMING THIS DUMP HAS CAUSED HIM TO REQUIRE MEDICAL ATTENTION. HE HAS A SEPARATION OF THE MUSCLE IN THE ABDOMEN, DIASTASES RECTI WHICH HE IS CLAIMING CAME FROM LEANING FORWARD IN A BACKWARD LEANING CHAIR. THE CHAIR WENT OUT WITH 24 INCH REAR WHEELS AND 8 INCH CASTERS. END USER STATES IT NOW HAS 6 INCH CASTERS AND 20 INCH REAR WHEEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356887 | 9XT SWINGAWAY FRAME STYLE 9153629153 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | 9XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |