MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-24 for VENT TUBE 1026011 ACTIVENT 5PK GOODE T G manufactured by Medtronic Xomed, Inc..
[3276583]
We received a copy of a facility medwatch report where the facility reported 'during surgical procedure for placement of ear tube physician noticed 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
[10718206]
(b)(4). The product was not returned for analysis or evaluation. No customer or user facility information was provided on the facility medwatch, therefore we were not able to obtain any additional information. Method: no testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00349 |
| MDR Report Key | 3075537 |
| Report Source | 06 |
| Date Received | 2013-04-24 |
| Date of Report | 2013-04-01 |
| Date of Event | 2012-05-25 |
| Date Mfgr Received | 2013-04-01 |
| Device Manufacturer Date | 2012-04-18 |
| Date Added to Maude | 2013-06-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENT TUBE 1026011 ACTIVENT 5PK GOODE T G |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2013-04-24 |
| Model Number | 1026011 |
| Catalog Number | 1026011 |
| Lot Number | 0205844151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-24 |