MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-26 for COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I EFX002 manufactured by Teleflex Medical.
| Report Number | 3011137372-2019-00201 |
| MDR Report Key | 8832572 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-07-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I |
| Generic Name | INSTRUMENT, LIGATURE PASSING A |
| Product Code | HCF |
| Date Received | 2019-07-26 |
| Catalog Number | EFX002 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-26 |