MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-10-11 for BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SET J-BICS-058020 manufactured by Cook Urological Inc..
[2154995]
Placed the bush ureteral illuminating stents for identification of ureters during the procedure. Pt later complained of abnormal amounts of blood in the urine and ended up in the er with a blood clot which was removed.
Patient Sequence No: 1, Text Type: D, B5
[9311612]
A proper eval cannot be performed due to the product not being returned. Info initially received from the facility using the device, the stimulating stents were placed for identification of the ureters during an endometriosis procedure. At this time additional info has been requested, upon receipt of further details, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2011-00040 |
| MDR Report Key | 2298290 |
| Report Source | 05,06,07 |
| Date Received | 2011-10-11 |
| Date of Report | 2011-09-21 |
| Date Mfgr Received | 2011-09-21 |
| Device Manufacturer Date | 2011-07-05 |
| Date Added to Maude | 2011-10-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 W. MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SET |
| Generic Name | FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2011-10-11 |
| Model Number | NA |
| Catalog Number | J-BICS-058020 |
| Lot Number | U2080012 |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-11 |