PDP FILTIP
Received Sep 6, 1995
Report MW1006854 · MDR key 25247
Device
Generic name
Filtip
Manufacturer
Pascal Professional DisposablesProduct problems
- False claim
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE DEVICE PURPORTEDLY REDUCES THE RISK OF CROSS CONTAMINATION, & MINIMIZES CONCERN FOR SUCKBACK. THERE IS NO EVIDENCE TO SUPPORT THESE CLAIMS. THERE IS NO BASIS FOR THE ASSERTION THAT THE FILTER IS OF MED GRADE, NOR WITH THE 2.5 MICRON PORES CAN IT BE EXPECTED TO FILTER OUT ANY PATHOGENIC ORGANISMS. THIS MED DEVICE CONTACTS MUCOUS MEMBRANES, & BODY FLUIDS BUT THERE IS NO EVIDENCE THAT IT PERFORMS AS ADVERTISED OR THAT IT HAS BEEN CLEARED FOR LEGAL MARKETING IN THE USA.