MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for MEDITECH TITANIUM GREENFIELD FILTER manufactured by Meditech.
[17258535]
56-year-old patient had an ivc filter placed on 12/1/93 without incident. Several hours later, the patient threw an embolus and expird. It is impossible to determine whether the embolus originated above or below the site of device placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16164 |
| MDR Report Key | 16164 |
| Date Received | 1994-07-21 |
| Date of Report | 1993-12-21 |
| Date of Event | 1993-12-01 |
| Date Facility Aware | 1993-12-21 |
| Report Date | 1994-01-05 |
| Date Reported to FDA | 1994-01-05 |
| Date Reported to Mfgr | 1994-01-05 |
| Date Added to Maude | 1994-09-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDITECH TITANIUM GREENFIELD FILTER |
| Generic Name | INFERIOR VENA CAUA FILTER |
| Product Code | DST |
| Date Received | 1994-07-21 |
| ID Number | DEVICE #50-301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16097 |
| Manufacturer | MEDITECH |
| Manufacturer Address | 480 PLEASANT STREET WATERTOWN MA 02172 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1994-07-21 |