MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-02-13 for PLAZLYTE STERILIZER ABT 1.0 PL006-01-02 manufactured by Abtox, Inc..
[92610]
Pt developed postop cornea endothelial cell decompensation. Surgical instruments were sterilized in the plazlyte process. Cause is unk. Similar surgeries were performed with instruments sterilized in the same process without adverse event. Published literature lists causes of corneal decompensation to include surgical techniques, residual detergent/gluteraldehyde, etc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939576-1998-00004 |
| MDR Report Key | 148933 |
| Report Source | 06 |
| Date Received | 1998-02-13 |
| Date of Report | 1998-01-30 |
| Date of Event | 1998-01-14 |
| Date Facility Aware | 1998-01-14 |
| Report Date | 1998-01-30 |
| Date Mfgr Received | 1998-01-30 |
| Date Added to Maude | 1998-02-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAZLYTE STERILIZER |
| Generic Name | GAS STERILIZER |
| Product Code | FLF |
| Date Received | 1998-02-13 |
| Model Number | ABT 1.0 |
| Catalog Number | PL006-01-02 |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 145140 |
| 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. Deathisabilit | 1998-02-13 |