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 2016-05-10 for NOVASHIELD? CG1000 manufactured by Medtronic Xomed Inc..
[44852859]
Product evaluation: analysis results not available; device discarded and will not be returned. (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[44852860]
It was reported that immediately following the procedure, the patient experienced "decreased o2 sats, pain, anxiety", and was admitted. "pain control only during first admission. " "discharged to home on (b)(6) 2016 after first admit with dx of deviated septum, s/p septoplasty with instructions to continue pre-op meds and the addition of pain medication. " patient returned to er experiencing "fever, weakness, wheezing and difficulty breathing". X-rays showed that "lung volumes are low. There is right basilar infiltrate suspicious for pneumonia. " patient admitted and "treated with ceftriazone and azithromycin. " second discharge was on (b)(6) 2016 with diagnosis of pneumonia and intractable sinus pain secondary to recent procedure and sent home with augmentin. " the patient has since recovered.
Patient Sequence No: 1, Text Type: D, B5
[101833379]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00137 |
| MDR Report Key | 5643333 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-10 |
| Date of Report | 2016-04-12 |
| Date of Event | 2016-03-07 |
| Date Mfgr Received | 2016-04-12 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2016-05-10 |
| 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 | NOVASHIELD? |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2016-05-10 |
| Model Number | CG1000 |
| Catalog Number | CG1000 |
| Lot Number | 0210445847 |
| Device Expiration Date | 2016-11-17 |
| 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 | 2016-05-10 |