MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-11-06 for NASAL SEPTAL BUTTON NSB-30 manufactured by Hood Laboratories.
[30421]
Button was implanted in 7/95 and separated on 9/19/96. The device was separated into two pieces, which had to be removed by the physician. Co was informed of this event on 10/9/96.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220850-1996-00001 |
| MDR Report Key | 47468 |
| Report Source | 05 |
| Date Received | 1996-11-06 |
| Date of Report | 1996-11-01 |
| Date of Event | 1996-09-19 |
| Date Mfgr Received | 1996-10-09 |
| Device Manufacturer Date | 1995-06-01 |
| Date Added to Maude | 1996-11-12 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASAL SEPTAL BUTTON |
| Generic Name | NASAL SEPTAL BUTTON |
| Product Code | LFB |
| Date Received | 1996-11-06 |
| Returned To Mfg | 1996-10-13 |
| Model Number | NSB-30 |
| Catalog Number | NSB-30 |
| Lot Number | 24085 |
| ID Number | * |
| Operator | NOT APPLICABLE |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 48268 |
| Manufacturer | HOOD LABORATORIES |
| Manufacturer Address | 575 WASHINGTON ST PEMBROKE MA 02359 US |
| Baseline Brand Name | NASAL SEPTAL BUTTON |
| Baseline Generic Name | NASAL SEPTAL BUTTON |
| Baseline Model No | NSB-30 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Baseline Device Family | NASAL SILICONE DEVICES |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K920994 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-11-06 |