MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-25 for EEA manufactured by Covidien.
[45916631]
(b)(4). During attempted placement of this device peroral, it became stuck and required 30-45 minutes to pass instead of 3 minutes as expected. Significant mucosal damage and bleeding occurred. It appeared that the device was not the right shape and was too big.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062465 |
| MDR Report Key | 5678957 |
| Date Received | 2016-05-25 |
| Date of Report | 2016-02-01 |
| Date of Event | 2016-02-01 |
| Date Added to Maude | 2016-05-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | EEA |
| Product Code | EEA |
| Date Received | 2016-05-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-25 |