MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-09-30 for ULTRACLIP II MARKER 864017 manufactured by Bd Peripheral Intervention.
| Report Number | 2020394-2019-03636 |
| MDR Report Key | 9137750 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-09-30 |
| Date of Report | 2019-09-30 |
| Date of Event | 2019-08-07 |
| Date Mfgr Received | 2019-09-03 |
| Date Added to Maude | 2019-09-30 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD SHANNON LIMITED |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO 00791 |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACLIP II MARKER |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | NEU |
| Date Received | 2019-09-30 |
| Model Number | 864017 |
| Catalog Number | 864017 |
| Lot Number | HUCX0340 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD PERIPHERAL INTERVENTION |
| Manufacturer Address | 1415 W. 3RD STREET TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-30 |