MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,literature report with the FDA on 2012-12-06 for TYMPANIC MEMBRANE PATCHER 1416010 5MM manufactured by Medtronic, Inc..
[2958260]
A literature review of an article published in the journal "the american journal of otology, inc. " 2000 entitled "tympanic membrane patcher: a new device to close tympanic membrane perforations in an office setting, by jack m. Kartush, department of otology and neurotology, providence hospital, southfield, michigan revealed a study involving tympathic membrane patchers in which several patients required medical intervention. No specific patient information is available. The following events were reported: three patients had rare otorrhea after patching and were treated by drops or temporary removal of the patcher. Two of these three ears subsequently became dry and then healed. One had dysfunction of the eustachian tube after radiation therapy and had two episodes of otorrhea treated by drops and, on one occasion, temporary removal of the patcher for 2 weeks. After repatching, the perforation healed. Two patients with persistent drainage were taken to surgery and were found to have mastoid disease (cholesteatoma or granulation tissue). The patcher required replacement or repositioning in eight patients because of lateralization or transient otorrhea. The patcher was removed in six patients because the ear remained wet or because the patient subsequently elected to undergo surgery. In one child in whom tympanoplasty had failed, otorrhea occurred once and was resolved with antibiotic drops. Note: no part numbers or lots were provided in the article. Part number 1416010 (tympanic membrane patcher 5mm) was assigned to this complaint for data entry purposes.
Patient Sequence No: 1, Text Type: D, B5
[10414666]
This device is used for therapeutic purposes. (b)(4). This complaint is being filed as a result of a literature review. No product will be returned for evaluation. The device was not returned and therefore no evaluation could be performed. The following codes were not available in medtronic's gch system: method: actual device not evaluated. Results: no results available since no evaluation performed. Conclusion: device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2012-00697 |
| MDR Report Key | 2860940 |
| Report Source | 03,LITERATURE |
| Date Received | 2012-12-06 |
| Date of Report | 2012-11-06 |
| Date Mfgr Received | 2012-11-06 |
| Date Added to Maude | 2012-12-07 |
| 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 | JONATHAN SCHLECH |
| 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 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 | TYMPANIC MEMBRANE PATCHER 1416010 5MM |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | KHJ |
| Date Received | 2012-12-06 |
| Model Number | 1416010 |
| Catalog Number | 1416010 |
| Lot Number | NOT PROVIDED |
| 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, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-06 |