MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-26 for STAMMBERGER SINUS DRESSING RR 650 manufactured by Arthrocare Corp..
[76060464]
Patient Sequence No: 1, Text Type: N, H10
[76060465]
It was reported that sinufoam stayed in the maxillary sinuses for 4-6 months causing an infection that required revision surgery.
Patient Sequence No: 1, Text Type: D, B5
[107038155]
Visual inspection and functional testing could not be performed because the product in question was not returned for evaluation. Thus, the customer? S complaint could not be verified, nor could a root cause be determined with confidence. It is possible the product was not sufficiently hydrated with lactated ringer solution or water, which could delay the timeline for product dissolution. It is also possible the patient did not irrigate properly after implantation. The instructions for use (ifu) provided with the device contains warnings and precautionary measures related to proper use of the device including but not limited to: - have the patient irrigate with light isotonic saline solution (0. 65%) until first office visit (do not irrigate with hypertonic saline solution or bulb style syringe until after first office visit). - any residual dressing that has not dissolved or left the surgical site through normal outflow passages may be easily aspirated at the discretion of the surgeon. There were no indications during manufacturing record review that would suggest the product did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2017-00133 |
| MDR Report Key | 6594138 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-26 |
| Date of Report | 2017-09-11 |
| Date of Event | 2016-09-16 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-05-26 |
| 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 W. WILLIAM CANNON |
| 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 | 3 |
| Brand Name | STAMMBERGER SINUS DRESSING |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2017-05-26 |
| Catalog Number | RR 650 |
| Lot Number | 4100203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Hospitalization | 2017-05-26 |