MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-03-30 for VENT TUBE VENT TUBE UNKNOWN manufactured by Medtronic Xomed Inc..
[103940291]
No evaluation performed. The devices were not returned for analysis. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[103940292]
This file will investigate the results reported in the article "laser myringotomy versus ventilation tubes in otitis media with effusion", yousaf, m. , et al;2016;28(4). Research objective: "it was aimed to compare results of laser myringotomy and ventilation tube insertion, in terms of hearing improvement and recurrence of middle ear effusion (mee). " a total of 68 patients (n=68) were treated with ventilation tube insertion. Of those patients, the following complications were rep orted: persistent hole: 2 (3%) http://www. Jamc. Ayubmed. Edu. Pk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2018-00140 |
| MDR Report Key | 7384964 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-30 |
| Date Mfgr Received | 2018-03-07 |
| Date Added to Maude | 2018-03-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR 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 |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2018-03-30 |
| Model Number | VENT TUBE UNKNOWN |
| Catalog Number | VENT TUBE UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-30 |