MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-04-11 for TULA TUBE DELIVERY SYSTEM TDSPAP101 manufactured by Acclarent, Inc..
[3277398]
Acclarent was notified on (b)(6) 2013, of an event that occurred on (b)(6) 2012, during a f/u visit to an otolaryngologist at a clinic. The otolaryngologist noted that the right tympanostomy tube had medialized behind the healed tympanic membrane. The surgeon reported that the pt was asymptomatic. The pt reportedly had no ear pain and/or ear infections. However, the otolaryngologist and the family elected to remove the tube from the middle ear under general anesthesia. This was done without any adverse reaction.
Patient Sequence No: 1, Text Type: D, B5
[10718002]
Acclarent followed up on this report to gather additional info. The vp of medical affairs contacted the reporting physician. The physician reported inserting the subject device with the acclarent tube delivery system on (b)(6) 2012. The procedure was said to be uneventful, and tube delivery system deployed the tube properly per the physician. The pt was seen for two or three postoperative visits over an unspecified period of time and had normalization of audiometric testing. During these visits the tympanostomy tube was observed in "normal acceptable position. " the pt later moved to another city, and several months later a different otolaryngologist noted that the right tympanostomy tube had medialized behind a healed tympanic membrane. The pt was reportedly not experiencing any pain or infections from the affected ear; however, the second otolaryngologist and the family elected to surgically remove the tube from the middle ear under general anesthesia. The pt was said to have tolerated the removal procedure well, and the status of the pt at this time is unk. Based on the info provided, it appears the tube delivery system worked appropriately, and the deployed tympanostomy tube remained in the intended position for several months. The pt's hearing issues, for which the tube was inserted, were said to have resolved. The exact cause of the reported medialization of the tympanostomy tube occurring after initial insertion is unk, but is a rare phenomenon that is referenced in literature. The rate of occurrence for this type of event does not appear to be occurring at a rate greater than expected for this type of device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2013-00015 |
| MDR Report Key | 3068091 |
| Report Source | 00 |
| Date Received | 2013-04-11 |
| Date of Report | 2013-03-13 |
| Date of Event | 2012-09-12 |
| Date Mfgr Received | 2013-03-12 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2013-04-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MONICA BARRETT |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506874948 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TULA TUBE DELIVERY SYSTEM |
| Generic Name | TYMPANOSTOMY TUBE DELIVERY SYSTEM |
| Product Code | ETD |
| Date Received | 2013-04-11 |
| Model Number | NA |
| Catalog Number | TDSPAP101 |
| Lot Number | 111118B |
| ID Number | NA |
| Device Expiration Date | 2012-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-11 |