MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for RESONANCE STENT SET G34111 RMS-060026-R manufactured by Cook Ireland Ltd.
[181214267]
(b)(4). Medical device: fad stent, ureteral.
Patient Sequence No: 1, Text Type: N, H10
[181214268]
According to the initial reporter, the physician attempted a bi-lateral stent exchange however was unable to retrieve the stents. It was later reported during the pcnl (percutaneous nephrolithotomy), a rigid cystoscope with flexible grasper were used.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3005580113-2020-00263 |
MDR Report Key | 9764548 |
Date Received | 2020-02-27 |
Date of Report | 2020-02-27 |
Date of Event | 2019-10-08 |
Date Facility Aware | 2020-02-04 |
Report Date | 2020-02-27 |
Date Reported to FDA | 2020-02-27 |
Date Reported to Mfgr | 2020-02-27 |
Device Manufacturer Date | 2018-05-16 |
Date Added to Maude | 2020-02-27 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RESONANCE STENT SET |
Product Code | FAD |
Date Received | 2020-02-27 |
Model Number | G34111 |
Catalog Number | RMS-060026-R |
Lot Number | C1484934 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COOK IRELAND LTD |
Manufacturer Address | O HALLORAN ROAD LIMERICK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-02-27 |