MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FUS-120045-P manufactured by Cook Inc.
[105518943]
This mdr is being filed after the associated complaint was reviewed under remediation protocol capa (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[105518944]
It was reported that during the procedure, the ureteral flexor had a split on the tip of dilator to feed the wire and there was a seam on the split that broke through and prevented the rapid release technique from working. The patient did not require any additional procedures nor experienced any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01062 |
| MDR Report Key | 7423366 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-11 |
| Date Mfgr Received | 2018-04-09 |
| Date Added to Maude | 2018-04-11 |
| 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 | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-04-11 |
| Catalog Number | FUS-120045-P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-11 |