MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2017-11-21 for MEDTRONIC VENT TUBE XOM UNK VENT TUBE manufactured by Medtronic Xomed Inc..
[92651085]
Product evaluation: analysis results are not available; device not returned for evaluation. Case 1 of 2 will be submitted on a separate mdr. Medtronic internal reference (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[92651086]
This report addresses adult 2 of 2 identified in the study. During a study of 56 patients to assess effectiveness of grommet insertion compared with non surgical treatment steroids in otitis media effusion (ome) cases, 2 adults were identified with permanent perforation of the tympanic membrane. The study is captured in the following literature article: chavan ss, nagpure ps. Comparative assessment of grommets with topical intranasal steroid in cases of otitis media with effusion. Indian j otology 2017; 23:146-50. Overall, "there was more improvement, less complications, and less failure rate in patient treated with myringotomy with grommet insertion than in patients which received intranasal steroids. " subjects of various age groups attending out patient department of ent, kasturba hospital, mgims sevagram, hospital, wardha from june 2013 to august 2015 who meet the inclusion criteria and gave their written consent in local language were included in the study. Doi (digital object identifier): 10. 4103/indianjotol. Indianjotol_46_17.
Patient Sequence No: 1, Text Type: D, B5
[102356410]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102356411]
Correction (case 2 of 2): it was confirmed that the perforation was not due to a defect or malfunction; rather, it was caused by "the aggressiveness" of the disease itself. None of the outcomes reported in the research were caused or contributed to by the vent tube. No additional procedures or medical interventions were required to treat the outcomes; the patients healed by themselves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00422 |
| MDR Report Key | 7049513 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-11-21 |
| Date of Report | 2018-02-23 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2017-11-21 |
| 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 | ANGIE DEMO |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| 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 | MEDTRONIC VENT TUBE |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2017-11-21 |
| Model Number | XOM UNK VENT TUBE |
| Catalog Number | XOM UNK VENT TUBE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-21 |