MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-20 for OSSEOFLEX STEERABLE NEEDLE OF-0231/B manufactured by Merit Medical Ireland Ltd.
| Report Number | 9616662-2019-00012 |
| MDR Report Key | 8913116 |
| Date Received | 2019-08-20 |
| Date of Report | 2019-07-22 |
| Date of Event | 2019-07-22 |
| Date Mfgr Received | 2019-10-01 |
| Device Manufacturer Date | 2019-04-23 |
| Date Added to Maude | 2019-08-20 |
| 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 | MRS. KATIE SWENSON CQE,CBA,CQPA. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012531600 |
| Manufacturer G1 | MERIT MEDICAL IRELAND LTD |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST BALLYBRIT |
| Manufacturer City | GALWAY, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSSEOFLEX STEERABLE NEEDLE |
| Generic Name | STEERABLE NEEDLE |
| Product Code | GAH |
| Date Received | 2019-08-20 |
| Catalog Number | OF-0231/B |
| Lot Number | K1567276 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL IRELAND LTD |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST BALLYBRIT GALWAY, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-20 |