MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-15 for SOLCO-TRANS ST-6500 manufactured by Solco-basle Hgp.
[3406]
Patient had right total hip replacement on 5/29/92. Solcotrans drain in place and discontinued later on 5/29/92. No drainage noted. Patient developed crepitus in right thigh which resolved within days. Patient readmitted 6/10/92 for evacuation of hematoma on right hip and thigh. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination, other. Results of evaluation: invalid data. Conclusion: invalid data, other. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5368 |
| MDR Report Key | 5368 |
| Date Received | 1993-03-15 |
| Date of Report | 1992-07-01 |
| Date Facility Aware | 1992-06-24 |
| Report Date | 1992-07-01 |
| Date Added to Maude | 1993-07-09 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLCO-TRANS |
| Generic Name | POST-OP AUTO TRANSFUSION SUSTEM |
| Product Code | LWE |
| Date Received | 1993-03-15 |
| Model Number | ST-6500 |
| Catalog Number | ST-6500 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5064 |
| Manufacturer | SOLCO-BASLE HGP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. No Informationnvalid Deathata | 1993-03-15 |