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 Scientific.
[21456]
Facility alleges that blood overflows into the transducer regardless of how tight fitted they are causing blood to clot. Ebl 150cc. No pt injury. Treatment not stopped. No medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00805 |
| MDR Report Key | 28523 |
| Date Received | 1995-11-15 |
| Date of Report | 1995-10-31 |
| Date of Event | 1995-10-09 |
| 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 | UNKNOWN |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 29474 |
| Manufacturer | GELMAN SCIENTIFIC |
| 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 |