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 2018-10-17 for NUVENT? 1830717FRT manufactured by Medtronic Xomed Inc..
[123977567]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123977568]
A health care provider (hcp) reported that during the functional endoscopic sinus surgery (fess), the patient had cerebrospinal fluid (csf) leak from the standard frontal balloon. They were alleging that it was due to the stiffness of the balloon. There was a 45 minute delay. They were able to stop the leak using a cartilage graft and some other device. The patient was observed overnight. There was no further issues or impact. The case was not aborted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2018-00518 |
| MDR Report Key | 7973886 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-09-20 |
| Date Added to Maude | 2018-10-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| 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 | NUVENT? |
| Generic Name | INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2018-10-17 |
| Model Number | 1830717FRT |
| Catalog Number | 1830717FRT |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-17 |