FDA Adverse Event
Malfunction
Summary report: N
9XT SWINGAWAY FRAME STYLE 9153629153
MDR report key: 4911743
·
Received July 14, 2015
Report
- Report Number
- 9616091-2015-01826
- Event Type
- Malfunction
- Date Received
- July 14, 2015
- Report Date
- August 7, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A RETURNED WAS ISSUED AND THE PRODUCT WAS EVALUATED UPON RECEIPT. THE COMPLAINT WAS CONFIRMED FOR THE BROKEN WELD AT THE HEAD TUBE. THE UNDERLYING CAUSE COULD NOT BE IDENTIFIED.
Additional Manufacturer Narrative · 1
A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.
Description of Event or Problem · 1
DEALER ADVISED LEFT FRAME BROKE AT A WELD WHERE HEADTUBE ATTACHES TO THE FRAME. SPOKE WITH (B)(4) IN TECH. TECH ADVISED DEALER NEEDS PART NUMBER 1074901. DEALER HUNG UP RECEIVED INFORMATION FROM TECH.
Description of Event or Problem · 1
DEALER ADVISED LEFT FRAME BROKE AT A WELD WHERE HEADTUBE ATTACHES TO THE FRAME. SPOKE WITH ALEX IN TECH. TECH ADVISED DEALER NEEDS PART NUMBER 1074901. DEALER HUNG UP RECEIVED INFORMATION FROM TECH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455375 | 9XT SWINGAWAY FRAME STYLE 9153629153 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | 9XDT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |