MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for NASASTENT RR1000 manufactured by Arthrocare Corp..
[98063142]
Patient Sequence No: 1, Text Type: N, H10
[98063143]
It was reported that following a fess, turbinate reduction, and septoplasty, the doctor cut the nasal dressing into two pieces (length wise) for use on both sides of the septum. The first half was able to be inserted, but the second half of the dressing could not be easily inserted. After several attempts with various instruments to insert the dressing into the correct anatomical space, the doctor medially sutured the septum to create a large enough space for the nasal dressing to be inserted before completing the surgery.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3006524618-2018-00035 |
MDR Report Key | 7195984 |
Date Received | 2018-01-16 |
Date of Report | 2018-02-21 |
Date of Event | 2017-12-20 |
Date Mfgr Received | 2018-02-16 |
Date Added to Maude | 2018-01-16 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
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 | NASASTENT |
Generic Name | SPLINT, INTRANASAL SEPTAL |
Product Code | LYA |
Date Received | 2018-01-16 |
Catalog Number | RR1000 |
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 | 2018-01-16 |