MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-11-13 for SINU FOAM RR 650 manufactured by Arthrocare Corp..
[126924212]
Patient Sequence No: 1, Text Type: N, H10
[126924213]
It was reported that another surgery had to be made to remove sinus foam since this caused growth of fungus in nasal cavity.
Patient Sequence No: 1, Text Type: D, B5
[131830093]
Without the return of the product, laboratory results or the requested clinical information we are unable to determine if the patient followed the instruction for use for the stammberger sinu foam. Proper use of the netti pot, or if the reported secretions prior to the 2018 procedure was retained sinu foam. Additionally, there is no evidence to support the smith and nephew product contributed to the reported fungal growth in the patient? S nasal cavity. Therefore, a root cause of the reported event cannot be determined. The occurrence of nasal cysts and benign polyps are common in patients with chronic sinusitis. The future impact to the patient cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2018-00590 |
| MDR Report Key | 8064155 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-11-13 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2018-11-13 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123485706 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINU FOAM |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2018-11-13 |
| Catalog Number | RR 650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-13 |