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 2016-05-09 for NOVASHIELD? CG1000 manufactured by Medtronic Xomed, Inc..
[44776892]
Product evaluation: analysis results not available; device discarded and will not be returned.
Patient Sequence No: 1, Text Type: N, H10
[44776893]
It was reported that 4 days after their initial procedure, the patient began experiencing "dyspnea and wheezing". The er performed a chest x-ray which diagnosed pneumonia. The surgeon prescribed levaquin and the patient was sent home. The patient returned to the er 3 days later, with the issue persisting. "ct done at er visit, right lung finding most consistent with pneumonia. " the patient was given "azithromycin, ceftriazone, and duoneb in er. " the patient was then "discharged to home from er with dx pneumonia and sent home with zithromax and albuterol and told to continue levaquin. " the patient has since recovered.
Patient Sequence No: 1, Text Type: D, B5
[101833539]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00135 |
| MDR Report Key | 5641873 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-09 |
| Date of Report | 2016-04-12 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-04-12 |
| Date Added to Maude | 2016-05-09 |
| 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 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 | NOVASHIELD? |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2016-05-09 |
| Model Number | CG1000 |
| Catalog Number | CG1000 |
| 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 DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-09 |