MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-25 for TRANSDUCER PROTECTOR manufactured by Gelman Sciences.
[14950]
Facility alleges leak during treatment. Rn reports transducer protector failed to hold pressure; fluid backed up into transducer. Constant interruption of blood flow led to clotting. Ebl > 100 cc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00334 |
| MDR Report Key | 21966 |
| Date Received | 1995-04-25 |
| Date of Report | 1995-04-17 |
| Date of Event | 1995-03-31 |
| Date Facility Aware | 1995-04-06 |
| Date Reported to FDA | 1995-04-17 |
| Date Reported to Mfgr | 1995-04-17 |
| Date Added to Maude | 1995-05-26 |
| 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 PROTECTOR |
| Generic Name | TRANSDUCER PROTECTOR |
| Product Code | FIB |
| Date Received | 1995-04-25 |
| Lot Number | 8638 |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22040 |
| Manufacturer | GELMAN SCIENCES |
| Manufacturer Address | ANN ARBOR MI 48106 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-04-25 |