MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-05 for ENDOSONIC CLEANER 100V (OT) 7500617 manufactured by Keymed (medical And Industrial Equipment) Ltd..
| Report Number | 9611174-2019-00012 |
| MDR Report Key | 8763618 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-07-05 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-06-24 |
| Date Mfgr Received | 2019-09-03 |
| Device Manufacturer Date | 2018-03-19 |
| Date Added to Maude | 2019-07-05 |
| 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 | 3 |
| Brand Name | ENDOSONIC CLEANER 100V (OT) |
| Generic Name | ENDOSONIC CLEANER |
| Product Code | FLG |
| Date Received | 2019-07-05 |
| Model Number | 7500617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-07-05 |