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 2020-02-14 for RAPIDRHINO UNKNOWN manufactured by Arthrocare Corp..
[187908249]
Foreign zip code: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187908250]
Literature case. It was reported a case of rapid rhino that was inserted into the nasal cavity and as soon as the balloon was inflated with air and before the cuff was taped on the cheek of the agitated patient, the pack disappeared and the patient said that he had swallowed it. The patient had only minor ooze from his right nostril after this event and was subsequently packed with a merocel sponge pack and admitted to the hospital. By late evening of the next day the patient had the clinical signs of peritonitis and a laparotomy was performed. The findings at operation were a small bowel perforation with a dilated and blood-filled small bowel. The rapid rhino was removed through the perforation in the ileum. The patient outcome is unknown. 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 | 3006524618-2020-00066 |
| MDR Report Key | 9714595 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-14 |
| Date of Report | 2020-04-01 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-02-14 |
| 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 | 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 | RAPIDRHINO |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2020-02-14 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 1. Other | 2020-02-14 |