MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-11 for REDDICK E2401-51 manufactured by Lemaitre Vascular, Inc.
| Report Number | 3007208013-2020-00003 |
| MDR Report Key | 9695915 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-01-01 |
| Date Added to Maude | 2020-02-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRANDI MEATH |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH, TN |
| Manufacturer Country | US |
| Manufacturer Phone | 9645290 |
| Manufacturer G1 | LAMAITRE VASCULAR,INC |
| Manufacturer Street | 43 2ND AVENUE |
| Manufacturer City | BURLINGTON, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDDICK |
| Generic Name | CHOLANGIOGRAM CATHETER |
| Product Code | GBZ |
| Date Received | 2020-02-11 |
| Model Number | E2401-51 |
| Catalog Number | E2401-51 |
| Lot Number | RST2649 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC |
| Manufacturer Address | 43 2ND AVENUE BURLINGTON, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |