MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-19 for 15 F ROUND FLUTED BLAKE DRAIN manufactured by Johnson & Johnson.
[18190640]
Status post fracture femur and orif. Removal of drainge catheter post-op left a 4 cm portion broken off in the proximal, lateral aspect of femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25750 |
| MDR Report Key | 25750 |
| Date Received | 1995-01-19 |
| Date of Report | 1994-10-03 |
| Date of Event | 1994-09-26 |
| Date Facility Aware | 1994-09-27 |
| Report Date | 1994-10-03 |
| Date Reported to Mfgr | 1994-10-05 |
| Date Added to Maude | 1995-09-19 |
| 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 | RISK MANAGER |
| 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 |
| Generic Name | 15 F ROUND FLUTED BLAKE DRAIN |
| Product Code | HOZ |
| Date Received | 1995-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 26351 |
| Manufacturer | JOHNSON & JOHNSON |
| Manufacturer Address | P.O. BOX 4000 NEW BRUNSWICK NJ 08903 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-19 |