MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-16 for DOVER CATHETER PLUG WITH CAP REF 1600 manufactured by Covidien.
| Report Number | MW5089826 |
| MDR Report Key | 9076008 |
| Date Received | 2019-09-16 |
| Date of Report | 2019-09-08 |
| Date of Event | 2019-08-29 |
| Date Added to Maude | 2019-09-17 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | DOVER CATHETER PLUG WITH CAP |
| Generic Name | URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER |
| Product Code | FCN |
| Date Received | 2019-09-16 |
| Model Number | REF 1600 |
| Lot Number | 1820404664 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 20248 US 20248 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-16 |