MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for SENSOR M0066703080 manufactured by Boston Scientific Corporation.
[184079298]
Patient underwent left percutaneous nephro lithotomy, antegrade ureteral stent placement, and laser incision of infundibular neck. After surgery, patient voided 3cm long grey thin foreign object. Object appeared to be tip of boston scientific dual flex sensor wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9853198 |
| MDR Report Key | 9853198 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-10-15 |
| Report Date | 2020-02-04 |
| Date Reported to FDA | 2020-02-04 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | SENSOR |
| Generic Name | STYLET FOR CATHETER, GASTRO-UROLOGY |
| Product Code | EZB |
| Date Received | 2020-03-19 |
| Model Number | M0066703080 |
| Catalog Number | M0066703080 |
| Lot Number | 24238998 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |