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..
[44851516]
Product evaluation: analysis results not available; device discarded and will not be returned.
Patient Sequence No: 1, Text Type: N, H10
[44851517]
It was reported that immediately following the procedure, the patient experienced "decreased o2 sats", and was admitted. X-rays showed "bilateral mid and lower lung edema, pneumonitis, and/or atelectasis. There are new small bilateral pleural effusions. A pneumothorax is not identified. " the patient was "given only fentanyl and ondansetron in er. Levaquin, clindamycin and duoneb given on floor. Discharged to home on (b)(6) 2015 with diagnosis aspiration pneumonitis and sent home on clindamycin. " the patient has since recovered.
Patient Sequence No: 1, Text Type: D, B5
[101833568]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00139 |
| MDR Report Key | 5643432 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-10 |
| Date of Report | 2016-04-12 |
| Date of Event | 2015-08-05 |
| Date Mfgr Received | 2016-04-12 |
| Device Manufacturer Date | 2015-05-07 |
| 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 | 0209576904 |
| Device Expiration Date | 2016-05-06 |
| 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 |