MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for SINU FOAM RR 650 manufactured by Arthrocare Corp..
[125904335]
Patient Sequence No: 1, Text Type: N, H10
[125904336]
It was reported that a stammberger sinus foam was used as packing after a cyst removal surgery (from nasal cavity). There was no bleeding that needed to be stopped. A year later, (b)(6) 2018, patient blew sinu foam out when blew nose. She had been in pain and had a horrible smell in nose and the pressure in her face was unreal, she thought that the cyst was back, and it was, but there was also sinu foam still in her face, which now grew a fungus as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2018-00573 |
| MDR Report Key | 8030518 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2018-11-01 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| 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 | 0 |
| Brand Name | SINU FOAM |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2018-11-01 |
| Catalog Number | RR 650 |
| Lot Number | UNKNOWN |
| 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 | 2018-11-01 |