MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-06 for BARD? FLUORO-4? SILICONE URETERAL COIL STENT 277406 manufactured by C.r. Bard, Inc. (covington) -1018233.
[182456038]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182456039]
It was reported that the fluoro-4 silicone stent was knotted on one end inside the patient. This was found due to the stents not draining properly. The urologist was able to remove the stent after careful retraction. Per additional information from the ibc via email (b)(6) 2020, the stent was removed from the patient using a cystoscopy and forceps. No additional intervention or treatment was required according to the urologist. The urologist was able to safely remove the stent, with no major injuries. However some stone fragments caught behind the knot might have caused minor irritation of the mucosa. No supplementary medication or additional treatment was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01631 |
| MDR Report Key | 9801107 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-06 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? FLUORO-4? SILICONE URETERAL COIL STENT |
| Generic Name | FLUORO-4? COIL SILICONE URETERAL STENT 6CH MULTILENGHT |
| Product Code | FAD |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 277406 |
| Catalog Number | 277406 |
| Lot Number | NGCV2405 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |