MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-15 for TRANSDUCER FILTER 04-9307-2 manufactured by Gelman Sciences, Inc..
[21459]
Facility alleges that blood overflows into transducer causing blood to clot. Ebl 237cc, no pt injury, no medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00809 |
| MDR Report Key | 28540 |
| Date Received | 1995-11-15 |
| Date of Report | 1995-10-31 |
| Date of Event | 1995-10-13 |
| Date Facility Aware | 1995-10-25 |
| Report Date | 1995-10-31 |
| Date Reported to FDA | 1995-11-01 |
| Date Reported to Mfgr | 1995-11-01 |
| Date Added to Maude | 1995-12-08 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | TRANSDUCER FILTER |
| Generic Name | TRANSDUCER FILTER |
| Product Code | FIB |
| Date Received | 1995-11-15 |
| Catalog Number | 04-9307-2 |
| Lot Number | 3610/3233 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29491 |
| Manufacturer | GELMAN SCIENCES, INC. |
| Manufacturer Address | 600 S WAGNER RD ANN ARBOR MI 48106 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-11-15 |