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 2019-07-22 for PASSPORT KIT M0062181300 218-130 manufactured by Boston Scientific Corporation.
| Report Number | 3005099803-2019-03625 |
| MDR Report Key | 8811035 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-22 |
| Date of Report | 2019-07-22 |
| Date of Event | 2019-05-13 |
| Date Mfgr Received | 2019-06-27 |
| Device Manufacturer Date | 2018-09-05 |
| Date Added to Maude | 2019-07-22 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASSPORT KIT |
| Generic Name | DILATOR, CATHETER, URETERAL |
| Product Code | EZN |
| Date Received | 2019-07-22 |
| Returned To Mfg | 2019-05-28 |
| Model Number | M0062181300 |
| Catalog Number | 218-130 |
| Lot Number | 0022608903 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-22 |