MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-14 for FRONTAL SINUS MINI-TREPHINE SET 1892000 manufactured by Medtronic Xomed, Inc..
[849012]
Event occurred in pt being treated for severe afs (allergic fungal sinusitis) and small left orbital mucocele. Irrigation through the minitrephine was initially uneventful with fungal debris movement and the fluorescein stained saline moving normally. After 20cc irrigation placed and irrigated, there was no flow through the nose. Noted left eye bulging, did a lateral canthotomy/cantholysis and medial decompression. Suspect a large blood of fungal debris blocked the irrigation outflow tract, and path of least resistance became the intraorbital route. Orbital exploration showed fluorescein stained saline in supero-medial compartment, ct showed supero-lateral fluid collection in orbit.
Patient Sequence No: 1, Text Type: D, B5
[8018405]
Event was described in discussions with the doctor. Abnormal or unusual variation in pt's anatomy caused the event and, therefore, it was not necessary to evaluate the device. Successful revision procedure was performed three days later. At that time, the doctor reported that the pt's vision was nearly normal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2008-00009 |
| MDR Report Key | 1045336 |
| Report Source | 05 |
| Date Received | 2008-05-14 |
| Date of Report | 2008-05-14 |
| Date of Event | 2008-04-14 |
| Date Mfgr Received | 2008-04-15 |
| Date Added to Maude | 2008-05-21 |
| 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 | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED |
| 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 | FRONTAL SINUS MINI-TREPHINE SET |
| Generic Name | SINUS TREPHINATION INSTRUMENT SET |
| Product Code | KBF |
| Date Received | 2008-05-14 |
| Model Number | 1892000 |
| Catalog Number | 1892000 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1015239 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-14 |