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 CHIOU SP TUBE INTRODUCER SET 075920 manufactured by Cook Urological Inc.
[2212604]
On (b)(6) 2011, a (b)(6) male had supra-pubic catheter (cook medical-chiou sp tube introducer set) placed. Pt had no previous urological procedures. On (b)(6) 2011 at time of urology clinic follow-up, md attempted cysto and noted a metallic object that appeared to be a wire fragment. On (b)(6) 2011, along with other urologic procedures, pt had foreign object (wire) removed (from bladder) while under anesthesia. Path report: 59x0. 1cm metallic wire. Pt is currently fine.
Patient Sequence No: 1, Text Type: D, B5
[9364578]
The device will not be returned, however, a cook employee has been cleared to go into the facility to view and photograph the device. The wire guide contained in this set measures 60cm in length and is an. 035" diameter noting the customer has indicated the portion removed was 59x0. 1cm. Following the eval of the device at the facility a report will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2011-00041 |
| MDR Report Key | 2298289 |
| Report Source | 05,06,07 |
| Date Received | 2011-10-11 |
| Date of Report | 2011-09-20 |
| Report Date | 2011-09-20 |
| Device Manufacturer Date | 2011-07-23 |
| 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 | 0 |
| 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 | CHIOU SP TUBE INTRODUCER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2011-10-11 |
| Model Number | NA |
| Catalog Number | 075920 |
| Lot Number | U2092840 |
| Device Expiration Date | 2014-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2011-10-11 |