MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-15 for ENDOMAT LC PUMP FOR SUCTION ONLY 20330320-1 manufactured by Karl Storz Se & Co. Kg.
Report Number | 9610617-2019-00108 |
MDR Report Key | 9329203 |
Report Source | OTHER |
Date Received | 2019-11-15 |
Date of Report | 2019-11-05 |
Date of Event | 2019-10-01 |
Date Mfgr Received | 2019-11-05 |
Device Manufacturer Date | 2014-06-01 |
Date Added to Maude | 2019-11-15 |
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 | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MRS. SUSIE CHEN |
Manufacturer Street | 2151 E. GRAND AVENUE |
Manufacturer City | EL SEGUNDO CA 902455017 |
Manufacturer Country | US |
Manufacturer Postal | 902455017 |
Manufacturer Phone | 4242188201 |
Manufacturer G1 | KARL STORZ SE & CO. KG |
Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
Manufacturer City | TUTTLINGEN, |
Manufacturer Country | GM |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ENDOMAT LC PUMP FOR SUCTION ONLY |
Generic Name | SUCTION PUMP |
Product Code | OCX |
Date Received | 2019-11-15 |
Model Number | 20330320-1 |
Catalog Number | 20330320-1 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | KARL STORZ SE & CO. KG |
Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-11-15 |