MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-02 for SUTURE PASSER NEEDLE 3910-900-091 manufactured by Coorstek Medical.
Report Number | 3004086872-2019-00002 |
MDR Report Key | 9538206 |
Report Source | DISTRIBUTOR |
Date Received | 2020-01-02 |
Date of Report | 2019-12-04 |
Date of Event | 2019-11-19 |
Date Mfgr Received | 2019-11-19 |
Device Manufacturer Date | 2018-05-21 |
Date Added to Maude | 2020-01-02 |
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 | 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 | 2020-01-02 |
Returned To Mfg | 2019-12-05 |
Model Number | 3910-900-091 |
Lot Number | 1415027 |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
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 | 2020-01-02 |