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 |