MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-30 for PRUITT AORTIC OCCLUSION 2100-12 * manufactured by Le Maitre Vascular.
[3742181]
The balloon had a hole in it. The catheter was taken off the sterile field and placed in a bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3364005 |
| MDR Report Key | 3364005 |
| Date Received | 2013-08-30 |
| Date of Report | 2013-08-30 |
| Date of Event | 2013-08-28 |
| Report Date | 2013-08-30 |
| Date Reported to FDA | 2013-08-30 |
| Date Reported to Mfgr | 2013-09-24 |
| Date Added to Maude | 2013-09-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | PRUITT AORTIC OCCLUSION |
| Generic Name | OCCLUDER, CATHETER TIP |
| Product Code | DQT |
| Date Received | 2013-08-30 |
| Model Number | 2100-12 |
| Catalog Number | * |
| Lot Number | PA 011101 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LE MAITRE VASCULAR |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-30 |