MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-10-13 for SILICONE - VENT TUBE - PAPARELLA-TYPE 24441 manufactured by Medtronic Xomed Inc..
[89351564]
Literature reference: doi 10. 1007/s00405-017-4617-5. Product evaluation: analysis results are not available; device not returned for evaluation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[89351565]
This file will investigate the results reported in the journal article? The effectiveness of myringotomy and ventilation tube insertion versus observation in post-radiation otitis media with effusion? , p. Charusripan, khattiyawittayakun; european archives of oto-r hino-laryngology (2017) 274:3283? 3290. The objective of the study is? To compare the effectiveness of myringotomy and ventilation tube insertion versus observation in postradiation otitis media with effusion (ome) in nasopharyngeal carcinoma (npc).? "post-radiation ome is common in patients with npc and tends to persist long-term. Conservative management is safe, however, is plagued by frustrating effects of hearing impairment and aural fullness. Myringotomy with ventilation tube insertion leads to hearing improvement with few complications. "? Two of 20 patients (10%) in the intervention group developed complications during follow-up, with one patient suffering suppurative otitis media whilst the other had otorrhea. Complications resolved after a week? S course of ofloxacin eardrops and oral ciprofloxacin therapy.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00365 |
| MDR Report Key | 6948483 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-10-13 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-10-13 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| 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 | SILICONE - VENT TUBE - PAPARELLA-TYPE |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2017-10-13 |
| Model Number | 24441 |
| Catalog Number | 24441 |
| 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. Required No Informationntervention | 2017-10-13 |