MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-06 for PDP FILTIP manufactured by Pascal Professional Disposables.
[13517]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006854 |
| MDR Report Key | 25247 |
| Date Received | 1995-09-06 |
| Date of Report | 1995-08-23 |
| Date Added to Maude | 1995-09-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDP FILTIP |
| Generic Name | FILTIP |
| Product Code | EIB |
| Date Received | 1995-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25724 |
| Manufacturer | PASCAL PROFESSIONAL DISPOSABLES |
| Manufacturer Address | P.O. BOX 1478 BELLEVUE WA 980091478 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-09-06 |