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 2019-07-24 for LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSM1350526 manufactured by Clearstream Technologies Ltd..
| Report Number | 9616666-2019-00087 |
| MDR Report Key | 8824486 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-24 |
| Date of Report | 2019-10-08 |
| Date of Event | 2019-06-26 |
| Date Mfgr Received | 2019-09-26 |
| Device Manufacturer Date | 2017-09-26 |
| Date Added to Maude | 2019-07-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | CLEARSTREAM TECHNOLOGIES LTD. |
| Manufacturer Street | MOYNE UPPER |
| Manufacturer City | ENNISCORTHY, CO. WEXFORD N A |
| Manufacturer Country | EI |
| Manufacturer Postal Code | N A |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT |
| Generic Name | BALLOON EXPANDABLE VASCULAR COVERED STENT |
| Product Code | PRL |
| Date Received | 2019-07-24 |
| Returned To Mfg | 2019-08-22 |
| Catalog Number | LSM1350526 |
| Lot Number | CMBW0482 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLEARSTREAM TECHNOLOGIES LTD. |
| Manufacturer Address | MOYNE UPPER ENNISCORTHY, CO. WEXFORD N A EI N A |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-24 |