MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-03 for SUTURE PASSER NEEDLE 3910-900-091 manufactured by Coorstek Medical.
| Report Number | 3004086872-2019-00003 |
| MDR Report Key | 9549317 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-13 |
| Date Mfgr Received | 2019-11-19 |
| Device Manufacturer Date | 2017-06-06 |
| Date Added to Maude | 2020-01-03 |
| 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 ROBERT BATES |
| Manufacturer Street | 867 WEST 400 NORTH |
| Manufacturer City | LOGAN UT 84321 |
| Manufacturer Country | US |
| Manufacturer Postal | 84321 |
| Manufacturer G1 | COORSTEK MEDICAL |
| Manufacturer Street | 867 WEST 400 NORTH |
| Manufacturer City | LOGAN UT 84321 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84321 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE PASSER NEEDLE |
| Generic Name | SUTURE PASSER NEEDLE |
| Product Code | GAB |
| Date Received | 2020-01-03 |
| Model Number | 3910-900-091 |
| Lot Number | 1251584 |
| Device Expiration Date | 2019-06-06 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COORSTEK MEDICAL |
| Manufacturer Address | 867 WEST 400 NORTH LOGAN UT 84321 US 84321 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |