MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-18 for OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE A22026A manufactured by Olympus Winter & Ibe Gmbh.
Report Number | 2951238-2019-01017 |
MDR Report Key | 8804572 |
Date Received | 2019-07-18 |
Date of Report | 2019-07-18 |
Date Facility Aware | 2019-06-21 |
Report Date | 2019-06-21 |
Date Reported to Mfgr | 2019-06-21 |
Date Added to Maude | 2019-07-18 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE |
Generic Name | OUTER SHEATH |
Product Code | GCP |
Date Received | 2019-07-18 |
Model Number | A22026A |
Catalog Number | A22026A |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | OLYMPUS WINTER & IBE GMBH |
Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-07-18 |