MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-04-29 for 15-24110 manufactured by Xomed Surgical Products, Inc..
[85555]
It was reported by user facility that "49 year old pt with nasal septal perforation, septal button placed 8/2/95, pt did well until 3/1/98. Spontaneous extrusion. Pt felt aspiration gave himself 2 heimleich manuevers and dislodged. He states connecting portion of prosthesis broken. " it was additionally reported to mfr that "pt is fine, no pre-existing medical conditions existed that contributed to event, device just came apart. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-1998-00002 |
| MDR Report Key | 165633 |
| Report Source | 00 |
| Date Received | 1998-04-29 |
| Date of Report | 1998-04-27 |
| Date of Event | 1998-03-01 |
| Date Mfgr Received | 1998-04-06 |
| Date Added to Maude | 1998-05-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | TWO-PART ADJUSTABLE SEPTAL BUTTON |
| Product Code | LFB |
| Date Received | 1998-04-29 |
| Model Number | NA |
| Catalog Number | 15-24110 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 154985 |
| Manufacturer | XOMED SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH 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 | 1998-04-29 |