MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-26 for STAMEY SUPRAPUBIC KIT G16922/G14099 manufactured by Cook Medical.
[3060481]
During urogynecology procedure, two attempts were made to place a suprapubic catheter. The first catheter broke at the joint between the catheter and the bib, the second would not penetrate the fascia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028395 |
| MDR Report Key | 2892862 |
| Date Received | 2012-12-26 |
| Date of Report | 2012-12-26 |
| Date of Event | 2012-12-20 |
| Date Added to Maude | 2013-01-03 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAMEY SUPRAPUBIC KIT |
| Generic Name | SUPRAPUBIC CATHETER |
| Product Code | KOB |
| Date Received | 2012-12-26 |
| Model Number | G16922/G14099 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | 1100 W MORGAN ST SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-26 |