MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-12 for FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FUS-120045-P manufactured by Cook Inc.
[142395599]
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[142395600]
As noted in mfr. Report # 1820334-2019-00775, the physician reported an incident occurred once in the past when using the cook access tubes for flexible ureteroscope (ch12 / 14, length 45 cm). In the previous report the complainant did state that there has been no patient damage to date, but there is a risk of tissue perforation due to the hydrophilic guide separates from the ureteral access sheath flexor-p during its placement in the patient. Additional patient and event details have been requested. At the time of this report, this is all of the information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00774 |
| MDR Report Key | 8511251 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-04-12 |
| 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 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | EZN DILATOR, CATHETER, URETERAL |
| Product Code | EZN |
| Date Received | 2019-04-12 |
| Catalog Number | FUS-120045-P |
| Lot Number | UNKNOWN |
| 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 INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |