MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-12 for SINU KNIT DISSOLVABLE DRESSING RR 600 manufactured by Arthrocare Corp..
[54507992]
Patient Sequence No: 1, Text Type: N, H10
[54507993]
It was reported that the patient had a post operative fibrotic tissue reaction after being treated with a sinu knit dissolvable dressing. No addtional details were provided regarding any treatment administered, however no additional patient complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
[58162350]
Visual inspection and functional testing could not be performed because the products in question were not returned for evaluation. Thus, the complaint could not be verified, nor could a root cause be determined with confidence. Factors unrelated to the manufacture or design of the products that could have contributed to the reported event include the patient? S general health, following post-operative instructions, or the presence of coexisting medical problems. The instructions for use provided with the devices contain information for use of the product including but not limited to: -"medical judgement is necessary when using rapid rhino sinu-knit dressings. "? Adverse reactions: these include the possibility of infection, recurrent or persistent bleeding, and dislodgement of the packing necessitating medical treatment. " there were no indications during manufacturing record review that would suggest that the products did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00236 |
| MDR Report Key | 5943867 |
| Date Received | 2016-09-12 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-08-12 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-09-12 |
| 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 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 | SINU KNIT DISSOLVABLE DRESSING |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2016-09-12 |
| Catalog Number | RR 600 |
| Lot Number | 1122839 |
| 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 | 2016-09-12 |