MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-01 for DOVER * 601709 manufactured by Sherwood Medical Co..
[165542]
Urine bag has a hole, and is leaking on the bottom right side. Put in surgery, package not saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016044 |
| MDR Report Key | 217148 |
| Date Received | 1999-04-01 |
| Date of Report | 1999-04-01 |
| Date of Event | 1999-02-02 |
| Date Added to Maude | 1999-04-06 |
| 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 | 1999-04-01 |
| 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 | 210635 |
| Manufacturer | SHERWOOD MEDICAL CO. |
| Manufacturer Address | 1915 OLIVE ST. ST LOUIS MO 631031642 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-04-01 |