MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-22 for NASASTENT RR1000 manufactured by Arthrocare Corp..
[44229264]
Patient Sequence No: 1, Text Type: N, H10
[44229345]
It was reported that the nasastent dressing failed to dissolve appropriately and pieces of the product fell into the maxillary area as discovered during post-op debridement. This resulted in protracted post-operative debridements (3) to remove the residual material and has caused the patient to experience a bad smell and nausea. No other patient complications have been reported. Additional post-operative treatments (b)(6) 2016 (report 1 of 3).
Patient Sequence No: 1, Text Type: D, B5
[47431866]
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 with lactated ringer's solution or water, which could delay the timeline for products' dissolution. It is also possible the patient did not irrigate properly after implantation. The instructions for use (ifu) provided with the devices contains warnings and precautionary measures related to proper use of the devices 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. " the raw material used for all rapid rhino products is tested for dissolution before being used in building the products. Manufacturing record review found no deviations during the manufacturing process related to the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00089 |
| MDR Report Key | 5600666 |
| Date Received | 2016-04-22 |
| Date of Report | 2016-06-10 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-04-11 |
| Date Added to Maude | 2016-04-22 |
| 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 DR. |
| 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 | 2016-04-22 |
| Catalog Number | RR1000 |
| Lot Number | 4100269 |
| Device Expiration Date | 2017-07-30 |
| 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 | 2016-04-22 |