MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-11 for ENDOSONIC CLEANER 100V (OT) 7500617 manufactured by Keymed (medical And Industrial Equipment) Ltd..
Report Number | 9611174-2019-00019 |
MDR Report Key | 8989989 |
Date Received | 2019-09-11 |
Date of Report | 2019-09-11 |
Date Mfgr Received | 2019-08-26 |
Device Manufacturer Date | 2017-03-01 |
Date Added to Maude | 2019-09-11 |
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 PETER MORCOS |
Manufacturer Street | KEYMED HOUSE, STOCK ROAD |
Manufacturer City | SOUTHEND ON SEA, ESSEX SS25QH |
Manufacturer Country | UK |
Manufacturer Postal | SS25QH |
Manufacturer Phone | 0441702616 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | ENDOSONIC CLEANER 100V (OT) |
Generic Name | ENDOSONIC CLEANER |
Product Code | FLG |
Date Received | 2019-09-11 |
Model Number | 7500617 |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
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 | 2019-09-11 |