MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-25 for MEROCEL 2000 * 470405 manufactured by Medtronic Xomed, Inc..
[675487]
Patient had functional rhinoplasty and submucous resection of the left inferior turbinate. A merocel airway splint was trimmed, saturated with bacitracin ointment. A silk pull-out suture was placed, and was put into the left nasal cavity. The patient was complaining of (c/o) coughing and sore thoat. Thirty six hours later the patient was unable to breathe. Performed heimlich maneuver on self, coughing up the nasal airway splint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 898945 |
| MDR Report Key | 898945 |
| Date Received | 2007-07-25 |
| Date of Report | 2007-07-25 |
| Report Date | 2007-07-25 |
| Date Reported to FDA | 2007-07-25 |
| Date Added to Maude | 2007-08-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEROCEL 2000 |
| Generic Name | NASAL PACKING W/AIRWAY |
| Product Code | EMX |
| Date Received | 2007-07-25 |
| Model Number | * |
| Catalog Number | 470405 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1.5 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 875129 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-25 |