MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-11 for SITE~RITE PROBE COVER KIT WITH GEL (48 IN) N/A 9001C0197 manufactured by Bard Access Systems.
| Report Number | 3006260740-2019-02966 |
| MDR Report Key | 9179747 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-11 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-09-17 |
| Date Mfgr Received | 2019-11-06 |
| Device Manufacturer Date | 2019-03-01 |
| Date Added to Maude | 2019-10-11 |
| 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 | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SITE~RITE PROBE COVER KIT WITH GEL (48 IN) |
| Generic Name | TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
| Product Code | ITX |
| Date Received | 2019-10-11 |
| Returned To Mfg | 2019-10-14 |
| Model Number | N/A |
| Catalog Number | 9001C0197 |
| Lot Number | REDQ0766 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-11 |