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 |