MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-12-23 for HYPERFORM BALLOON 104-4770 manufactured by Micro Therapeutics, Inc. Dba Ev3.
| Report Number | 2029214-2019-01291 |
| MDR Report Key | 9511746 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-12-23 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-04-04 |
| Date Added to Maude | 2019-12-23 |
| 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 | MGR. KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERFORM BALLOON |
| Generic Name | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY |
| Product Code | MJN |
| Date Received | 2019-12-23 |
| Returned To Mfg | 2020-01-13 |
| Model Number | 104-4770 |
| Lot Number | A809888 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-23 |