MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2013-01-03 for VENT TUBE 1016010 5PK GOODE T 1.14X12MM manufactured by Xomed Mfg Jacksonville.
[3059546]
It was reported to medtronic that in (b)(6) 2012 (exact date unknown) a vent tube was implanted in a (b)(6) male patient. After the implant procedure, the patient experienced inflammation, purulence and infection. The physician is considering explanting the device.
Patient Sequence No: 1, Text Type: D, B5
[10494305]
This device is used for therapeutic purposes. The exact implant date is unknown, but was reported to be (b)(6) 2012. (b)(4). The device remains implanted and will not be returned for evaluation. The device was not returned and therefore, no evaluation could be performed.
Patient Sequence No: 1, Text Type: N, H10
[10527567]
Additional information received (b)(4) 2013 confirmed the device was explanted. The explant date is unknown. The patient was treated with antibiotics and was reported to be ok. The device will not be returned as it was discarded. The patient's medical history includes middle ear effusion.
Patient Sequence No: 1, Text Type: N, H10
[101021433]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00007 |
| MDR Report Key | 2895319 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2013-01-03 |
| Date of Report | 2012-12-04 |
| Date Mfgr Received | 2013-02-17 |
| Device Manufacturer Date | 2012-06-29 |
| Date Added to Maude | 2013-01-03 |
| 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 | VENT TUBE 1016010 5PK GOODE T 1.14X12MM |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2013-01-03 |
| Model Number | 1016010 |
| Catalog Number | 1016010 |
| Lot Number | 0206005229 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MFG JACKSONVILLE |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-03 |