MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-20 for KOMED SILASTIC NS BUTTON * 15-24110 3CM 2-PART manufactured by Komed Surgical Products.
[107866]
A 49 yr old pt w/nasal septal perforation had a septal button placed 8/2/95. Pt did well until 3/1/98. Spontaneous extrusion occurred. Pt felt aspiration gave himself 2 heimlich maneuvers and dislodged it. He stated connecting portion of prosthesis was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013371 |
| MDR Report Key | 159121 |
| Date Received | 1998-03-20 |
| Date of Report | 1998-03-06 |
| Date of Event | 1998-03-01 |
| Date Added to Maude | 1998-03-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOMED SILASTIC NS BUTTON |
| Generic Name | SILASTIC NASAL SEPTAL BUTTON |
| Product Code | LFB |
| Date Received | 1998-03-20 |
| Model Number | * |
| Catalog Number | 15-24110 3CM 2-PART |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 154985 |
| Manufacturer | KOMED SURGICAL PRODUCTS |
| Manufacturer Address | 6743 SOUTHPOINT DR. N. JACKSONVILLE FL 32216 US |
| Baseline Brand Name | SILICONE NASAL SEPTAL BUTTON |
| Baseline Generic Name | NASAL SEPTAL BUTTON |
| Baseline Model No | NA |
| Baseline Catalog No | 15-24110 |
| Baseline ID | NA |
| Baseline Device Family | NASAL SEPTAL BUTTONS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K791529 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1998-03-20 |