MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-01 for KARL STORZ 27033 17114-000 manufactured by .
Report Number | 8770942 |
MDR Report Key | 8770942 |
Date Received | 2019-07-01 |
Date of Report | 2019-06-28 |
Date of Event | 2019-06-11 |
Date Facility Aware | 2019-06-11 |
Report Date | 2019-06-11 |
Date Reported to FDA | 2019-06-24 |
Date Reported to Mfgr | 2019-06-28 |
Date Added to Maude | 2019-07-09 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | KARL STORZ |
Generic Name | THIN PEDI SYSTEM |
Product Code | FBO |
Date Received | 2019-07-01 |
Model Number | 27033 |
Catalog Number | 17114-000 |
Lot Number | STZPDICYS-000 |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer Address | 1 S. LOS CARNEROS ROAD GOLETA CA 93117 US 93117 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2019-07-01 |