MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for 7.5CM ANTERIOR/POSTERIOR RR 750 manufactured by Arthrocare Corp..
[142221369]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[142221370]
It was reported that during an unknown procedure the patient was packed bi-laterally with rapid rhino following tumour de-bulking procedure. They don? T know when and if the balloon was inflated. As the patient was waking, they observed that the patient had difficulty breathing. They removed the rapid rhino and observed that it appear to have come apart. The piece in the laryngopharnxy was removed under laryngoscopy. They also removed more material from the nasal airway under endoscopy. Immediate de -gloving of rapid rhino pack with alginate and ending up in laryngeal inlet. Patient could not breath, laryngoscopy was performed to remove alginate from laryngeal inlet, and the nose was packed with bipp (bismuth iodine paraffine paste).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2019-00190 |
| MDR Report Key | 8520496 |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-04-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | 0 |
| Brand Name | 7.5CM ANTERIOR/POSTERIOR |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2019-04-16 |
| Catalog Number | RR 750 |
| Lot 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 | 2019-04-16 |