MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-08-09 for OTOLOGY VENT TUBE XOM UNK OTOLOGY manufactured by Medtronic Xomed Inc..
[82332076]
Online link to article: http://www. Ijporlonline. Com/article/s0165-5876(16)30466-9/fulltext. Product evaluation: analysis results are not available; device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[82332077]
Results reported in? Hearing sensitivity in adults with a unilateral cleft lip and palate after two-stage palatoplasty? , i. F. P. M. Kappen, et al. , international journal of pediatric otorhinolaryngology 94 (2017) 76-81. ? Objective: to evaluate long-term hearing and middle ear status in patients treated for a unilateral complete cleft lip and palate (uclp) by two-stage palatoplasty.? This study found? A positive correlation between the frequency of tube insertion and hearing loss was observed, indicated by the pta for air conduction (0. 435, p = 0. 001). There was a significantly higher pharyngoplasty incidence in the group that had received ventilation tubes (p = 0. 013).? ? Abnormal eardrum compliance, which was associated with vt insertion in our series, may therefore contribute to the hearing loss observed within our group. Because of the multifactorial cause of hearing loss in uclp patients, it remains however difficult to assess to what extent vt insertion contributes to the incidence of hl. Inflammatory associated middle ear damage also has a role.? ? Our high incidence of velopharyngeal incompetence during early childhood, which is likely associated with eustachian tube dysfunction, might have contributed to these results.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00275 |
| MDR Report Key | 6778438 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-08-09 |
| Date of Report | 2017-07-13 |
| Date Mfgr Received | 2017-07-13 |
| Date Added to Maude | 2017-08-09 |
| 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 | OTOLOGY VENT TUBE |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2017-08-09 |
| Model Number | XOM UNK OTOLOGY |
| Catalog Number | XOM UNK OTOLOGY |
| 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. Deathisabilit | 2017-08-09 |