MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-10-18 for VM-T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM 2130814BT / NL 4252-83T manufactured by S.u.a. Martin Gmbh &co.kg.
Report Number | 8010386-2019-00003 |
MDR Report Key | 9210020 |
Report Source | DISTRIBUTOR |
Date Received | 2019-10-18 |
Date of Report | 2019-10-18 |
Date of Event | 2019-08-26 |
Date Mfgr Received | 2019-09-18 |
Device Manufacturer Date | 2008-03-21 |
Date Added to Maude | 2019-10-18 |
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. MARKUS PAULI |
Manufacturer Street | UHLANDSTRASSE 17 |
Manufacturer City | RIETHEIM-WEILHEIM, 78604 |
Manufacturer Country | GM |
Manufacturer Postal | 78604 |
Manufacturer G1 | S.U.A. MARTIN GMBH &CO.KG |
Manufacturer Street | UHLANDSTRASSE 17 |
Manufacturer City | RIETHEIM-WEILHEIM, 78604 |
Manufacturer Country | GM |
Manufacturer Postal Code | 78604 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VM-T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 3MM |
Generic Name | MANUAL RONGEUR |
Product Code | HAE |
Date Received | 2019-10-18 |
Catalog Number | 2130814BT / NL 4252-83T |
Lot Number | XMEI05 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | S.U.A. MARTIN GMBH &CO.KG |
Manufacturer Address | UHLANDSTRASSE 17 RIETHEIM-WEILHEIM, 78604 GM 78604 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-10-18 |