MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-14 for IDEA'S PORT IP2001 manufactured by Ideas For Medicine.
[15289]
Catheteeer came apaart from port - free floating in suiperior vena cava. Device labeled for single use. Patient medical status prior to event: unknown. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 34696-1994-00003 |
| MDR Report Key | 25318 |
| Date Received | 1995-04-14 |
| Date of Report | 1994-06-24 |
| Date of Event | 1994-05-26 |
| Report Date | 1994-06-24 |
| Date Reported to FDA | 1994-06-24 |
| Date Reported to Mfgr | 1994-06-24 |
| Date Added to Maude | 1995-08-31 |
| 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 | IDEA'S PORT |
| Generic Name | VENOUS ACCESS PORT |
| Product Code | LKG |
| Date Received | 1995-04-14 |
| Model Number | IP2001 |
| Catalog Number | IP2001 |
| Lot Number | D092293-21-61 |
| Operator | OTHER |
| Device Availability | * |
| Device Age | 01-OCT-93 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 25817 |
| Manufacturer | IDEAS FOR MEDICINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-04-14 |