MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-27 for CONTURA * B012-45 manufactured by Hologic, Inc.
[4514144]
Patient had contura partial radiation catheter placed. Prior to placement the surgeon checked the balloon. After placement patient had ct scan at outpatient treatment center to ensure placement and balloon patency; which was good. Three days later the patient returned to outpatient treatment center for treatment and the balloon had popped. Radiation treatment could not be completed and the catheter was removed. Patient was offered to have another catheter placed but patient declined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3918240 |
| MDR Report Key | 3918240 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-27 |
| Date of Event | 2014-06-16 |
| Report Date | 2014-06-27 |
| Date Reported to FDA | 2014-06-27 |
| Date Reported to Mfgr | 2014-07-08 |
| Date Added to Maude | 2014-07-08 |
| 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 | 3 |
| 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 | CONTURA |
| Generic Name | CATHETER |
| Product Code | JAQ |
| Date Received | 2014-06-27 |
| Model Number | * |
| Catalog Number | B012-45 |
| Lot Number | REXJ0575 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-27 |