SCALACOMBI S36
Received Jun 1, 2017 · Event occurred Apr 13, 2017
Report 3004730072-2017-00005 · MDR key 6605704
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
57 YR
- Head Injury
- Head Injury
Narrative
Additional Manufacturer Narrative
CORE ID:CI1496342818518.13364574@FDSUV08638_TE1, BATCH ID: 3004730072-20170601144658, DATE ENTERED: THU JUN 01 14:53:14 EDT 2017, WAS ENTERED IN ERROR. THE SAME INFORMATION CAN BE FOUND IN: CORE ID:CI1495036931479.20286355@FDSUV08637_TE1, BATCH ID: 3004730072-20170517120211, DATE ENTERED: WED MAY 17 12:10:39 EDT 2017, SUMMARY: PASSED:1, FAILED:0.
Additional Manufacturer Narrative
DEVICE RETURNED TO MANUFACTURER, NO MALFUNCTION FOUND.
Description of Event or Problem
WHILE THE WIFE WAS USING THE SCALACOMBI S36 TO TRANSPORT HER HUSBAND DOWN THE STAIRS, THE DEVICE ALLEGEDLY TILTED SIDEWAYS TO THE WALL CAUSING HER HUSBAND TO HIT HIS HEAD. THE HUSBAND WAS ADMITTED TO THE HOSPITAL FOR HEAD INJURY AND LACERATIONS. THE EVENT OCCURRED IN (B)(6).