MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-29 for SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE SSNF manufactured by Pressure Products Medical Device Manufacturing Llc.
| Report Number | 3013986346-2020-00001 |
| MDR Report Key | 9644694 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2019-12-31 |
| Device Manufacturer Date | 2019-08-07 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANDREW ARMOUR |
| Manufacturer Street | 1 SCHOOL STREET |
| Manufacturer City | MORTON PA 19070 |
| Manufacturer Country | US |
| Manufacturer Postal | 19070 |
| Manufacturer Phone | 6102859858 |
| Manufacturer G1 | PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC |
| Manufacturer Street | 1 SCHOOL STREET |
| Manufacturer City | MORTON PA 19070 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE |
| Generic Name | NEEDLE FREE TRANSSEPTAL GUIDEWIRE |
| Product Code | DRC |
| Date Received | 2020-01-29 |
| Model Number | SSNF |
| Catalog Number | SSNF |
| Lot Number | 000625 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC |
| Manufacturer Address | 1 SCHOOL STREET MORTON PA 19070 US 19070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |