MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-05 for STAMMBERGER SINUS DRESSING RR 650 manufactured by Arthrocare Corp..
[94283169]
Patient Sequence No: 1, Text Type: N, H10
[94283170]
It was reported that despite mixing the stammberger sinufoam rr650 with sterile water as she had in the past, it did not dissolve but stayed in its full form. There was no patient injury reported. There was no backup device available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2017-00390 |
| MDR Report Key | 7083035 |
| Date Received | 2017-12-05 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2018-02-02 |
| Device Manufacturer Date | 2017-04-30 |
| Date Added to Maude | 2017-12-05 |
| 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 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 | STAMMBERGER SINUS DRESSING |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2017-12-05 |
| Returned To Mfg | 2017-12-27 |
| Catalog Number | RR 650 |
| Lot Number | 4100492 |
| Device Expiration Date | 2019-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-12-05 |