MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-17 for HYDRODEBRIDER? FRONTAL HANDPIECE 1921002 manufactured by Medtronic Xomed Inc..
[70252280]
Product evaluation: analysis results not available; the device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[70252281]
After using the fusion and nuvent? Frontal sinus dilation balloon, the frontal sinuses were irrigated with the hydrodebrider. The patient presented with swelling of the conjunctival eyelids. Irrigation was stopped. The surgeon decompressed the patient's right eyelid and reduced the swelling by performing a lateral canthotomy, taking down the medial orbital wall. Since the swelling was pre-septal, the doctor believes that the entry of the saline was not related to the use of the nuvent or the sinus dissection, but believes that this patient, who has a history of facial trauma, had a preexisting dehiscence of the orbit that was too small to show up in the pre or post operative ct's that were taken. The patient has recovered; there are no complications. The surgery time was extended for one hour as the orbital decompression was added to the procedure, and an ophthalmologist was called in to assist. A postoperative ct confirmed there was no fluid in the brain or remaining in the right orbit. The surgeon confirmed that "the lateral canthotomy and medial orbital wall decompression were preventative. "
Patient Sequence No: 1, Text Type: D, B5
[101835635]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2017-00086 |
| MDR Report Key | 6412900 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-17 |
| Date of Report | 2017-02-22 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2017-01-25 |
| Date Added to Maude | 2017-03-17 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| 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 | HYDRODEBRIDER? FRONTAL HANDPIECE |
| Generic Name | IRRIGATOR, POWERED NASAL |
| Product Code | KMA |
| Date Received | 2017-03-17 |
| Model Number | 1921002 |
| Catalog Number | 1921002 |
| Lot Number | 0212678328 |
| 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 NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-17 |