MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-10 for TRANSDUCER PROTECTOR manufactured by Gelman Sciences.
[16069]
Facility alleges leaks during dialysis. Transducer protector not holding pressure. Became wet. Low venous pressure resulted; blood circuit discarded. Ebl 300 cc. Treatment restarted with new dialyzer. No further problems reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00399 |
| MDR Report Key | 22307 |
| Date Received | 1995-05-10 |
| Date of Report | 1995-04-24 |
| Date of Event | 1995-03-09 |
| Date Facility Aware | 1995-04-18 |
| Report Date | 1995-04-29 |
| Date Added to Maude | 1995-06-08 |
| 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 PROTECTOR |
| Generic Name | TRANSDUCER PROTECTOR |
| Product Code | FIB |
| Date Received | 1995-05-10 |
| Lot Number | 9155 |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22433 |
| Manufacturer | GELMAN SCIENCES |
| Manufacturer Address | 600 S WAGNER ROAD ANN ARBOR MI 48106 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-05-10 |