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 2019-04-17 for PROXIS? URETERAL ACCESS SHEATH 231235 manufactured by C.r. Bard, Inc. (covington) -1018233.
[142186586]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[142186587]
It was reported that the patient's ureter allegedly tore when the physician inserted the proxis access sheath into the ureter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-01966 |
| MDR Report Key | 8522220 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-04-17 |
| Date of Report | 2019-06-20 |
| Date Mfgr Received | 2019-06-03 |
| Date Added to Maude | 2019-04-17 |
| 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 | PROXIS? URETERAL ACCESS SHEATH |
| Generic Name | ACCESS SHEATH |
| Product Code | FED |
| Date Received | 2019-04-17 |
| Model Number | 231235 |
| Catalog Number | 231235 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other; 2. Required No Informationntervention | 2019-04-17 |