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 2020-03-20 for BARD? INLAY? URETERAL STENT 778624 manufactured by C.r. Bard, Inc. (covington) -1018233.
[184297183]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Patient Sequence No: 1, Text Type: N, H10
[184297184]
It was reported that the urosoft stent did not allow for drainage. Per additional information received via email on 2 march 2020 from the sales representative, the stent was placed on (b)(6) 2020. The dr. Discovered that the stent allegedly caused the blockage of urine. The patient required an additional procedure for the stent to be removed. The stent was replaced with another stent on (b)(6) 2020 to allow drainage of urine
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01975 |
| MDR Report Key | 9859399 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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? INLAY? URETERAL STENT |
| Generic Name | URETERAL STENT |
| Product Code | FAD |
| Date Received | 2020-03-20 |
| Catalog Number | 778624 |
| Lot Number | ANBY2982 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-20 |