FDA Adverse Event
Malfunction
Summary report: N
ADJUSTABLE BASE ONLY 9153618937
MDR report key: 4823405
·
Received June 8, 2015
Report
- Report Number
- 3008262382-2015-01320
- Event Type
- Malfunction
- Date Received
- June 8, 2015
- Report Date
- May 18, 2015
- Manufacturer
- INVACARE REHABILITATION EQUIPMENT CO.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.
Description of Event or Problem · 1
(B)(4). THE PROVIDER STATES THE CASTER IS BROKEN ON THE BASE FROM ORDER NUMBER (B)(4). NO INJURIES NOTED. THE CALLER DIDN'T HAVE ADDITIONAL INFORMATION REGARDING THE ISSUE (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367202 | ADJUSTABLE BASE ONLY 9153618937 | LIFT, PATIENT, NON-AC-POWERED | FSA | INVACARE REHABILITATION EQUIPMENT CO. | 9884 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |