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 2018-04-18 for 7.5CM ANTERIOR/POSTERIOR UNKNOWN manufactured by Arthrocare Corp..
[105839065]
Patient Sequence No: 1, Text Type: N, H10
[105839066]
It was reported that a patient presented with epistaxis and was treated with rapid rhino. This did not control the epistaxis so patient was taken into theatre to attempt to stop the bleeding. This failed and the patient died from blood loss. There is no information that indicates smith and nephews device was a factor, malfunctioned, caused or contributed to the death.
Patient Sequence No: 1, Text Type: D, B5
[110066710]
This is a complaint that was created from a literature review in an irish publication, the journal i. E. Printed on march 23, 2018. The article reported of an event that occurred in july 2016 to an approximately(b)(6) year old male with unknown medical history. Initially it was inferred that a rapid rhino product could have been used to treat the patient. After treatment the patient was discharged from the hospital, with the advice to follow up with his gp. The patient returned to the hospital by ambulance the next evening after collapsing and reports of continued bleeding throughout the day by his partner. The bleeding was described as? Torrential?. The product that was used in treatment could not be identified after several attempts nor was it returned for evaluation. Without confirmation and return of the subject device we cannot determine if there is a relationship between the product and the incident. Thus, the complaint could not be verified, nor could a root cause be determined with confidence. Based on the information, in the article and from the sales representative, this was not a failure of the rapid rhino system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2018-00193 |
| MDR Report Key | 7440513 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-18 |
| Date of Report | 2018-06-04 |
| Date of Event | 2016-07-15 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-04-18 |
| 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 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 | 3 |
| Brand Name | 7.5CM ANTERIOR/POSTERIOR |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2018-04-18 |
| Catalog Number | UNKNOWN |
| 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. Death | 2018-04-18 |