MalfunctionMBP
DBP PUTTY 5CC
Received Jun 22, 2012
Report 2090010-2012-00003 · MDR key 2629162
Device
Product problems
- Contamination /Decontamination Problem
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
CUSTOMER REPORTED BLACK SPOTS WERE OBSERVED IN THE PRODUCTS. CUSTOMER BELIEVES IT MIGHT BE MOLD. THE PRODUCT WAS NOT USED ON PT.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.