MalfunctionILM
MALIBU/SOVEREIGN (INCLU. DIGNITY)
Received Aug 9, 2013
Report 9611530-2013-00102 · MDR key 3297510
Device
Manufacturer
Arjo Hospitla Equipment AbProduct problems
- Defective Component
Patient
Not reported
- Abrasion
- Head Injury
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJO (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.