MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-09-03 for MILTEX 5-290 SAME manufactured by Milex Instrument Co., Inc..
[92061]
Tip of curved scissor broke during use in an invasive nasal reconstruction surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431021-1997-00008 |
| MDR Report Key | 117533 |
| Report Source | 05 |
| Date Received | 1997-09-03 |
| Date of Report | 1997-09-02 |
| Date of Event | 1997-08-13 |
| Date Mfgr Received | 1997-09-02 |
| Date Added to Maude | 1997-09-08 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILTEX |
| Generic Name | RAGNELL DISSECTING SCISSOR, 5" |
| Product Code | KBD |
| Date Received | 1997-09-03 |
| Returned To Mfg | 1997-09-02 |
| Model Number | 5-290 |
| Catalog Number | SAME |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 115267 |
| Manufacturer | MILEX INSTRUMENT CO., INC. |
| Manufacturer Address | 6 OHIO DRIVE-CB5006 LAKE SUCCESS NY 110420006 US |
| Baseline Brand Name | MILTEX |
| Baseline Generic Name | RAGNELL DISSECTING SCISSOR, 5" |
| Baseline Model No | 5-290 |
| Baseline Catalog No | SAME |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-09-03 |