MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-11 for 11.5FX20CM SIL.DBLMN HEMO-C SE SL20E manufactured by Medical Components, Inc..
| Report Number | 2518902-2020-00014 |
| MDR Report Key | 9818286 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-02-28 |
| Date Added to Maude | 2020-03-11 |
| 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 | LYNN WINKLER |
| Manufacturer Street | 1499 DELP DRIVE |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal | 19438 |
| Manufacturer Phone | 2152564201 |
| Manufacturer G1 | MEDICAL COMPONENTS, INC. |
| Manufacturer Street | 1499 DELP DRIVE |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11.5FX20CM SIL.DBLMN HEMO-C SE |
| Generic Name | HEMO-CATH ST |
| Product Code | MSD |
| Date Received | 2020-03-11 |
| Model Number | SL20E |
| Catalog Number | SL20E |
| Lot Number | MNGX260 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL COMPONENTS, INC. |
| Manufacturer Address | 1499 DELP DRIVE HARLEYSVILLE PA 19438 US 19438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |