MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-17 for ANTIMICROBIAL VENTILATION TUBE 1026011 manufactured by Medtronic Xomed, Inc.
[3318342]
During surgical procedure for placement of ear tube physician notice a bug in the new ear tube prior to insertion in the patient. Reason for use: nonsuppurative otitis media. Eustacian tube disorder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029400 |
| MDR Report Key | 3015645 |
| Date Received | 2013-03-17 |
| Date of Report | 2013-03-17 |
| Date of Event | 2012-05-25 |
| Date Added to Maude | 2013-03-22 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTIMICROBIAL VENTILATION TUBE |
| Generic Name | TUBE |
| Product Code | ETD |
| Date Received | 2013-03-17 |
| Model Number | 1026011 |
| Lot Number | 0205844151 |
| ID Number | 1026011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-17 |