MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-10 for 7.5CM ANTERIOR/POSTERIOR RR750 manufactured by Arthrocare Corp..
[45152400]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[45152401]
It was reported that the rapid rhino fell apart in the patient's nose making removal difficult. There have been no reported patient complications.
Patient Sequence No: 1, Text Type: D, B5
[48024442]
Visual examination and materials testing of the returned product confirmed the presence of nylon in the cmc/nylon knit on the rr 750 device. The presence of nylon confirms that there was not a production error during manufacturing. The design of the device requires the nylon in the cmc/nylon knit to re-enforce the fabric. This keeps it intact during placement/use. 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 device that could have contributed to the reported event is the patient following post-operative instructions, device not wetted per ifu prior to placement, device wetted with solution other than sterile water, or technique in the removal process. The instructions for use (ifu) outlines warning, precautionary measures and instructions regarding the use of the product. There were no indications to suggest the product did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00107 |
| MDR Report Key | 5644612 |
| Date Received | 2016-05-10 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-04-19 |
| Date Mfgr Received | 2016-04-19 |
| Date Added to Maude | 2016-05-10 |
| 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 | 7.5CM ANTERIOR/POSTERIOR |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2016-05-10 |
| Returned To Mfg | 2016-05-31 |
| Catalog Number | RR750 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-05-10 |