MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-20 for B3855, SILH XTRAFLO URTL STENT 6FX22CM 100964607 manufactured by Applied Medical Resources.
[182327508]
No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A follow up report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[182327509]
Patient procedure: "stent implanted (b)(6) 2019, cysto stent placement" "while at home, patient spontaneously had ureter stent dislodge and fall out when urinating. The upper coil is still in the body. " "will have surgery again. " intervention: patient requires a second surgery. Patient status: "will have surgery again. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00371 |
| MDR Report Key | 9735457 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2018-08-30 |
| Date Added to Maude | 2020-02-20 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B3855, SILH XTRAFLO URTL STENT 6FX22CM |
| Generic Name | STENT, URETERAL |
| Product Code | FAD |
| Date Received | 2020-02-20 |
| Model Number | B3855 |
| Catalog Number | 100964607 |
| Lot Number | 1335215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |