MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for RECOVERY manufactured by Bard Peripheral Vascular, Inc..
[124657509]
Recovery ivc filter found to be fractured with three arms embolized to the pulmonary arteries. Filter and all fragments removed successfully using percutaneous techniques.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080694 |
| MDR Report Key | 7984432 |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-10-17 |
| Date Added to Maude | 2018-10-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RECOVERY |
| Generic Name | IVC FILTER |
| Product Code | MMX |
| Date Received | 2018-10-18 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | TEMPE AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-10-18 |