MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for RESONANCE STENT SET G34111 RMS-060026-R manufactured by Cook Ireland Ltd.
[188819622]
Fad stent, ureteral.
Patient Sequence No: 1, Text Type: N, H10
[188819663]
As initially reported to customer relations via email from customer to district manager: the metal stands we recently placed are not draining. She is back on nephrostomy drainage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005580113-2020-00202 |
| MDR Report Key | 9701564 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-19 |
| Date Facility Aware | 2020-02-12 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-02-12 |
| Device Manufacturer Date | 2019-11-04 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| Model Number | G34111 |
| Catalog Number | RMS-060026-R |
| Lot Number | C1664662 |
| 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 | 2020-02-12 |