MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-16 for LIFE PORT NONE LPS 5013 manufactured by Strato Medical Corporation.
[8]
Surgeon removed a malfunctioning port-a-cath "life port" by strato on february 3, 1992. A portion of the silastic catheter had broken off and was retrieved from the pulmonary artery in radiologyinvalid data - regarding single use labeling of device. 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. Invalid data - regarding whether event presents imminent hazard. 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: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 37 |
| MDR Report Key | 37 |
| Date Received | 1992-03-16 |
| Date of Report | 1992-02-28 |
| Date Facility Aware | 1992-02-03 |
| Report Date | 1992-02-28 |
| Date Reported to FDA | 1992-02-28 |
| Date Reported to Mfgr | 1992-02-18 |
| Date Added to Maude | 1992-03-23 |
| 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 | LIFE PORT |
| Generic Name | PORT-A-CATH SYSTEM |
| Product Code | GBS |
| Date Received | 1992-03-16 |
| Model Number | NONE |
| Catalog Number | LPS 5013 |
| Lot Number | 90884 |
| ID Number | PAT. NO. 4673394 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 35 |
| Manufacturer | STRATO MEDICAL CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-03-16 |