MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for FLUSHING PUMP OFP-2 (US) K10001141 manufactured by Keymed (medical And Industrial Equipment) Ltd..
Report Number | 2951238-2020-00360 |
MDR Report Key | 9807027 |
Date Received | 2020-03-09 |
Date of Report | 2020-03-09 |
Date of Event | 2020-02-10 |
Date Facility Aware | 2020-02-10 |
Report Date | 2020-02-10 |
Date Reported to Mfgr | 2020-02-10 |
Date Added to Maude | 2020-03-09 |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | FLUSHING PUMP OFP-2 (US) |
Generic Name | OLYMPUS FLUSHING PUMP |
Product Code | FEQ |
Date Received | 2020-03-09 |
Model Number | K10001141 |
Device Availability | * |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
Manufacturer Address | KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA, ESSEX SS2 5QH UK SS2 5QH |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-03-09 |