MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2017-10-27 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS FUS-120045 manufactured by Cook Inc.
[91075255]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[91075256]
The distributor reported that prior to use, the user facility observed a white stain at the distal end of the flexor ureteral access sheath. This device was not used. There was no contact with the patient. As reported, there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-03747 |
| MDR Report Key | 6983508 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2017-10-27 |
| Date of Report | 2018-01-22 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2018-01-10 |
| Device Manufacturer Date | 2017-07-06 |
| Date Added to Maude | 2017-10-27 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXOR URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2017-10-27 |
| Catalog Number | FUS-120045 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-27 |