FDA Adverse Event
Malfunction
Summary report: N
TRANSPORT 20 IN X 16 IN 9153637574
MDR report key: 4818974
·
Received June 4, 2015
Report
- Report Number
- 9616091-2015-01500
- Event Type
- Malfunction
- Date Received
- June 4, 2015
- Report Date
- May 14, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED
Description of Event or Problem · 1
PROVIDER ALLEGES, THE SCREWS ARE STRIPPED. JOHN IN TECH WANTS TO HAVE PART NUMBER 1170576 SENT BACK AS A RETURN FOR QUALITY REVIEW AND OR THE ENTIRE CHAIR TO DETERMINE MANUFACTURE DEFECT OR PHYSICAL ABUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362844 | TRANSPORT 20 IN X 16 IN 9153637574 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | SPREE3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |