MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-05 for 1.25MM THREADED GUIDE WIRE 150MM 292.620S manufactured by Oberdorf Synthes Produktions Gmbh.
Report Number | 8030965-2020-01655 |
MDR Report Key | 9793905 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
Date Received | 2020-03-05 |
Date of Report | 2020-02-18 |
Date of Event | 2020-01-07 |
Date Mfgr Received | 2020-02-18 |
Date Added to Maude | 2020-03-05 |
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 | KARA DITTY-BOVARD |
Manufacturer Street | 1302 WRIGHTS LANE EAST |
Manufacturer City | WEST CHESTER PA 19380 |
Manufacturer Country | US |
Manufacturer Postal | 19380 |
Manufacturer Phone | 6103142063 |
Manufacturer G1 | MONUMENT |
Manufacturer Street | 1101 SYNTHES AVENUE |
Manufacturer City | MONUMENT CO 80132 |
Manufacturer Country | US |
Manufacturer Postal Code | 80132 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 1.25MM THREADED GUIDE WIRE 150MM |
Generic Name | WIRE,SURGICAL |
Product Code | LRN |
Date Received | 2020-03-05 |
Catalog Number | 292.620S |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-05 |