MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-13 for FLEXOR FUS-120035-DL G46079 manufactured by Cook Urological Incorporated.
[4043296]
Patient had a flexible ureteroscopy with biopsy of right renal mass and stent insertion. Patient readmitted 6 days later with pelvic abscess. Possible ureteral injury. Abscess not at biopsy site. ====================== manufacturer response for ureteral access sheath, flexor dl dual lumen ureteral access sheath (per site reporter). ====================== i just filled out a product complaint form today and forwarded it to the vendor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3496255 |
| MDR Report Key | 3496255 |
| Date Received | 2013-11-13 |
| Date of Report | 2013-11-13 |
| Date of Event | 2013-10-02 |
| Report Date | 2013-11-13 |
| Date Reported to FDA | 2013-11-13 |
| Date Reported to Mfgr | 2013-12-03 |
| Date Added to Maude | 2013-12-03 |
| 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 | FLEXOR |
| Generic Name | URETERAL ACCESS SHEATH |
| Product Code | FGA |
| Date Received | 2013-11-13 |
| Model Number | FUS-120035-DL |
| Catalog Number | G46079 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INCORPORATED |
| Manufacturer Address | 1100 WEST MORGAN STREET SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-13 |