MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-16 for ABTOX ABT 1.0 * manufactured by Abtox, Inc..
[143745]
Md reports cornea degeneration. Facility used abtox system to sterilize surgical instruments until 4/1/98.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 201951 |
MDR Report Key | 201951 |
Date Received | 1998-12-16 |
Date of Report | 1998-10-02 |
Date of Event | 1998-02-10 |
Report Date | 1998-10-02 |
Date Reported to Mfgr | 1998-10-02 |
Date Added to Maude | 1998-12-17 |
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 | ABTOX |
Generic Name | PLAZLYTE STERILIZATION SYSTEM |
Product Code | FLF |
Date Received | 1998-12-16 |
Model Number | ABT 1.0 |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Operator | OTHER |
Device Availability | Y |
Device Age | 5 MO |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 196157 |
Manufacturer | ABTOX, INC. |
Manufacturer Address | 104 TERRACE DRIVE MUNDELEIN IL 60060 US |
Baseline Brand Name | PLAZLYTE STERILIZER |
Baseline Generic Name | GAS STERILIZER |
Baseline Model No | ABT 1.0 |
Baseline Catalog No | PL006-01-02 |
Baseline ID | * |
Baseline Shelf Life [Months] | NA |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K905119 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1998-12-16 |