MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-20 for DOVER * 601709 manufactured by Sherwood Medical.
[14865835]
The foley bag blue clip doesn't close completely. It leaks where it is supposed to close together. They reopened it and closed it thinking it would close. It still leaked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016179 |
| MDR Report Key | 220203 |
| Date Received | 1999-04-20 |
| Date of Report | 1999-04-20 |
| Date of Event | 1999-04-19 |
| Date Added to Maude | 1999-04-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOVER |
| Generic Name | URINARY DRAINAGE |
| Product Code | FCN |
| Date Received | 1999-04-20 |
| Model Number | * |
| Catalog Number | 601709 |
| Lot Number | 808407 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 213569 |
| Manufacturer | SHERWOOD MEDICAL |
| Manufacturer Address | 1915 OLIVE ST. ST LOUIS MO 63103 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-04-20 |