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 2019-04-16 for 9CM ANTERIOR/POSTERIOR DUAL RR 900 manufactured by Arthrocare Corp..
[142115535]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[142115536]
It was reported that patient was waking from anesthesia and it was observed that patient had difficulty breathing. They removed the rapid rhino and it appeared to has come apart. The patient de saturated and blood could be heard gurgling. The piece in the laryngopharynx was removed under laryngoscopy. They also removed more material from the nasal airway under endoscopy. Patient is fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2019-00189 |
| MDR Report Key | 8519689 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-16 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-05-20 |
| Date Added to Maude | 2019-04-16 |
| 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 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 | 9CM ANTERIOR/POSTERIOR DUAL |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2019-04-16 |
| Catalog Number | RR 900 |
| 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. Other | 2019-04-16 |