FDA Adverse Event
Injury
Summary report: N
MAXIMOVE (GLOUCESTER)
MDR report key: 4143735
·
Received August 13, 2014
Report
- Report Number
- 1419652-2014-00203
- Event Type
- Injury
- Date Received
- August 13, 2014
- Date of Event
- July 13, 2014
- Report Date
- July 18, 2014
- Manufacturer
- ARJO MED AB LTD.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED BY THE COMPANY REP THAT DURING THE PT'S TRANSFER IN THE SLING, THE PT FELL DOWN DUE TO WRONG SIZE OF THE SLING USAGE - TOO LARGE. AS A CONSEQUENCE OF THE EVENT, THE PT RECEIVED A SIMPLE BUMP TO THE HEAD WITH HEMATOMA. IT WAS INDICATED THAT THE PT WAS SENT TO THE EMERGENCY ROOM. MFR REF # 9611530-2014-00059.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 483391 | MAXIMOVE (GLOUCESTER) | FSA | ARJO MED AB LTD. | KRA300: SLING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |