MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-17 for STAMEY PERCUTANEOUS SUPRAPUBIC CATHETER UNKNOWN 081014 manufactured by Cook Urological.
[12060]
Cystoscopy for removal of fragment of suprapublic catheter from bladder. Catheter tip broke off while physician removing catheter during office visit of 10/15/93.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16323 |
| MDR Report Key | 16323 |
| Date Received | 1994-02-17 |
| Date of Report | 1993-10-22 |
| Date of Event | 1993-10-20 |
| Date Facility Aware | 1993-10-20 |
| Report Date | 1993-10-22 |
| Date Added to Maude | 1994-09-22 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAMEY PERCUTANEOUS SUPRAPUBIC CATHETER |
| Generic Name | 14 FR MALECOT CATHETER |
| Product Code | FEW |
| Date Received | 1994-02-17 |
| Model Number | UNKNOWN |
| Catalog Number | 081014 |
| Lot Number | 115947 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16256 |
| Manufacturer | COOK UROLOGICAL |
| Manufacturer Address | P.O. BOX 227 SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-02-17 |