MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for PROXIS? URETERAL ACCESS SHEATH 231235 manufactured by C.r. Bard, Inc. (covington) -1018233.
[144097891]
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
[144097892]
It was reported that the ureteral access sheath was used during a procedure of calculus removal in calyx. A fibrous foreign material was found in the kidney. Then, the foreign material was removed with an endoscope. The facility requested to confirm if the foreign matter was derived from the ureteral access sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-02316 |
| MDR Report Key | 8579205 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-07-01 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-06-17 |
| Date Added to Maude | 2019-05-03 |
| 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 | 0 |
| Brand Name | PROXIS? URETERAL ACCESS SHEATH |
| Generic Name | URETERAL ACCESS SHEATH |
| Product Code | FED |
| Date Received | 2019-05-03 |
| Returned To Mfg | 2019-04-24 |
| Catalog Number | 231235 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-03 |