MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-28 for RICHARDS/SOLCOTRANS PLUS DRAINAGE/REINFUSION SYSTEM ST-6200 manufactured by Solco Basle, Inc..
[17436707]
It was reported dthat the wound drain broke in the joint when the surgeon attempted to remove the drain. Subsequently, the surgeon had to open the patient to remove the draindevice labeled for single use. Patient medical status prior to event: invalid data. 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. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-1993-00002 |
| MDR Report Key | 5948 |
| Date Received | 1993-01-28 |
| Date of Report | 1993-01-07 |
| Report Date | 1993-01-07 |
| Date Reported to FDA | 1993-01-07 |
| Date Reported to Mfgr | 1992-12-23 |
| Date Added to Maude | 1993-07-29 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | RICHARDS/SOLCOTRANS PLUS DRAINAGE/REINFUSION SYSTEM |
| Generic Name | DRAINAGE/REINFUSION SYSTEM |
| Product Code | DQI |
| Date Received | 1993-01-28 |
| Catalog Number | ST-6200 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 5646 |
| Manufacturer | SOLCO BASLE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-01-28 |