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 2017-09-08 for NASASTENT RR1000 manufactured by Arthrocare Corp..
[85269726]
Patient Sequence No: 1, Text Type: N, H10
[85269727]
It was reported that the nasastent dressing failed to dissolve appropriately post-operatively causing the patient to experience tissue inflammation, headaches and a bad smell. The residual material in the sinus cavity was suctioned out 2 months post-surgery with no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
[113291564]
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 customer? S complaint could not be verified, nor could a root cause be determined with confidence. There were no indications that would suggest that the product did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2017-00252 |
| MDR Report Key | 6851011 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-08 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-05-13 |
| Date Mfgr Received | 2017-11-21 |
| Date Added to Maude | 2017-09-08 |
| 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 | NASASTENT |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2017-09-08 |
| Catalog Number | RR1000 |
| Lot Number | 4100359 |
| 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 | 1. Required No Informationntervention | 2017-09-08 |