MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-16 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
| Report Number | 1220948-2019-00089 |
| MDR Report Key | 8794452 |
| Date Received | 2019-07-16 |
| Date of Report | 2019-07-15 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-06-17 |
| Device Manufacturer Date | 2017-12-18 |
| Date Added to Maude | 2019-07-16 |
| 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 | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2019-07-16 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1386V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Required No Informationntervention | 2019-07-16 |