MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-12 for DOVER SILICON FOLEY CATH TRAY 8887-641762 NA manufactured by Sherwood Medical.
[122352]
Unable to void after surgery; unable to insert foley catheter: bedside cystoscopy done with 600 + cc bloody urine returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013169 |
| MDR Report Key | 156264 |
| Date Received | 1998-03-12 |
| Date of Report | 1998-02-02 |
| Date of Event | 1998-01-15 |
| Date Added to Maude | 1998-03-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 SILICON FOLEY CATH TRAY |
| Generic Name | 16 FRENCH 5CC BALLOON |
| Product Code | FCN |
| Date Received | 1998-03-12 |
| Model Number | 8887-641762 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 152218 |
| Manufacturer | SHERWOOD MEDICAL |
| Manufacturer Address | 1915 OLIVE ST. ST. LOUIS MO 631031642 US |
| Baseline Brand Name | CLOSED SYSTEM FOLEY CATHETER TRAY, SILICONE |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-641762 |
| Baseline ID | * |
| Baseline Device Family | UROLOGICAL CATHETER & ACCESSORIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K810630 |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-03-12 |