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 2016-11-07 for NASASTENT RR1000 manufactured by Arthrocare Corp..
[59292970]
Patient Sequence No: 1, Text Type: N, H10
[59292971]
It was reported that the nasastent dressing failed to dissolve appropriately after a fess/turbinectomy case. The patient had to go back to the or two-weeks post-operatively for washout as the residual material had caused the patient to become septic. No additional information provided regarding subsequent treatment or current health status of the patient, however, no other complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
[62413534]
The product, used in treatment, was not returned for evaluation. A relationship, if any, between the product and the reported event could not be determined since the product was not returned for evaluation. Visual inspection and functional testing could not be performed because the product in question was not returned for evaluation. Thus, the complaint could not be verified, nor could a root cause be determined with confidence. It is 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: - "after placement, nasastent dressing may be hydrated if desired. " - "nasastent dressing is dissolvable and any residual material that has not dissolved or left the surgical site through normal outflow passages can be removed with irrigation and aspiration. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00297 |
| MDR Report Key | 6082932 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-07 |
| Date of Report | 2016-12-14 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Date Added to Maude | 2016-11-07 |
| 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 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 | 3 |
| Brand Name | NASASTENT |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2016-11-07 |
| Catalog Number | RR1000 |
| Lot Number | UNKNOWN |
| 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. Required No Informationntervention | 2016-11-07 |