MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-14 for BBL FIBROMETER 60415 H8292-213413 manufactured by Becton Dickinson Microbiology.
[22187353]
Pt was on heparin drip since admission (7/7/95). Continuously monitored by ptt's labwork coagulation levels. Bolus dose was given based on lab values. Clinically demonstrated evidence of multiple hematomas (bleeding). Confirmation received of lab ptt greater than 100 (previously 30-40). Heparin was held and pt was monitored closely with no further evidence of bleeding. Maintained status pain free and hemodynamically stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24324 |
| MDR Report Key | 24324 |
| Date Received | 1995-07-14 |
| Date of Event | 1995-07-09 |
| Date Facility Aware | 1995-07-10 |
| Date Reported to FDA | 1995-07-14 |
| Date Added to Maude | 1995-08-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | BBL FIBROMETER |
| Generic Name | PRECISION COAGULATION TIMER |
| Product Code | GIE |
| Date Received | 1995-07-14 |
| Catalog Number | 60415 H8292-213413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24689 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY |
| Manufacturer Address | COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-07-14 |