MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-13 for BIG EASY 1156603 7114128 manufactured by Medtronic.
[42956099]
Pt had a previous staple prosthesis replaced. It had failed/broken during or after previous procedure. The device is a "big easy" staple prosthesis. Dates of use: (b)(6) 2014. Diagnosis or reason for use: broken prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061747 |
| MDR Report Key | 5584306 |
| Date Received | 2016-04-13 |
| Date of Report | 2016-04-13 |
| Date of Event | 2016-03-03 |
| Date Added to Maude | 2016-04-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIG EASY |
| Generic Name | STAPLES |
| Product Code | ETA |
| Date Received | 2016-04-13 |
| Model Number | 1156603 |
| Catalog Number | 7114128 |
| Lot Number | 0207247969 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-13 |