FDA Adverse Event
Other
Summary report: N
ALENTI
MDR report key: 1878549
·
Received October 1, 2010
Report
- Report Number
- 9611530-2010-00070
- Event Type
- Other
- Date Received
- October 1, 2010
- Date of Event
- September 17, 2010
- Report Date
- September 17, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (B)(4), ARJO INC, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
AS STATED BY THE CUSTOMER ON (B)(6) 2010: "ALENTI WITH PT FELL OVER." (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALENTI | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO HOSPITAL EQUIPMENT AB | CDB8001-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR |