MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-04 for TRANSDUCER PROTECTOR 04-9207-4 manufactured by Gelman Sciences.
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Facility alleged that blood is backing up into the tp's and causing the dialyzer's to clot off. They also report using 30 tp's for a 13 hr shift. There were no pt injuries or medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00851 |
| MDR Report Key | 28990 |
| Date Received | 1995-12-04 |
| Date of Report | 1995-12-01 |
| Date of Event | 1995-10-23 |
| Date Facility Aware | 1995-11-22 |
| Report Date | 1995-12-01 |
| Date Reported to FDA | 1995-12-01 |
| Date Reported to Mfgr | 1995-12-01 |
| Date Added to Maude | 1995-12-27 |
| 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 | 1995-12-04 |
| Catalog Number | 04-9207-4 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 29988 |
| Manufacturer | GELMAN SCIENCES |
| Manufacturer Address | 600 S WAGNER RD ANN ARBOR MI 481061448 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-12-04 |