MalfunctionFMP
SQUISHON 3
Received Aug 21, 2014
Report 1218950-2014-07540 · MDR key 4330081
Device
Product problems
- Leak/Splash
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED THEY RECEIVED 10, 91033-3 SQUISHON 3 THAT SOME WERE MOLDY AND SOME WERE LEAKING. THERE WAS NO REPORTED PATIENT INCIDENT/INJURY.