MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-17 for NASASTENT RR1000 manufactured by Arthrocare Corp..
[45369289]
Patient Sequence No: 1, Text Type: N, H10
[45369290]
It was alleged that two patients experienced headaches, pressure and bleeding during use of nasastent resulting in the doctors decision to discontinue use of the product. No medical/surgical intervention or other patient complications have been reported. Report 2 of 2.
Patient Sequence No: 1, Text Type: D, B5
[50676300]
Visual inspection and functional testing could not be performed because the product 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 product was not sufficiently hydrated, which could delay the timeline for product dissolution. Additional factors unrelated to the device used in the procedure that could have contributed to the reported event include the health of the patient and compliance with post-operative instructions. The instructions for use (ifu) provided with the device contains warnings and precautionary measures related to proper use of the device a review of the device history records did not identify any deficiencies in the material or process. There were no indications that would suggest the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00115 |
| MDR Report Key | 5660335 |
| Date Received | 2016-05-17 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-05-12 |
| Date Mfgr Received | 2016-05-12 |
| Date Added to Maude | 2016-05-17 |
| 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 | 2016-05-17 |
| Catalog Number | RR1000 |
| Lot Number | 4100269 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-05-17 |