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 2020-03-24 for 9CM ANTERIOR/POSTERIOR DUAL RR 900 manufactured by Arthrocare Corp..
[187909491]
It was reported that a patient had high-velocity impact to his face by a fence post that caused extensive facial injuries, and a glasgow coma scale fluctuating between 3 and 6. He was intubated at the scene and during transit he developed brisk epistaxis therefore a 9 cm rapid rhino was used. The nasal balloon was seen to be extending through the cribriform plate and was situated within the left frontal lobe therefore it was deflated and removed manually in the emergency department. At the end, a shorter 5. 5-cm rapid rhino was used, with correct positioning confirmed radiographically. The patient had a prolonged stay in the intensive care unit and was treated prophylactically with antibiotics to prevent intracranial infection. The rapid rhino was removed after 72 hours and no further epistaxis occurred. Serial imaging demonstrated development of a traumatic encephalocele which was surgically repaired via bifrontal craniotomy. He made an uneventful recovery following this procedure and was discharged home after intensive neurorehabilitation in the hospital brain injuries rehabilitation unit. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2020-00123 |
| MDR Report Key | 9875862 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| 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 | 9CM ANTERIOR/POSTERIOR DUAL |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2020-03-24 |
| Catalog Number | RR 900 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2020-03-24 |