MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-16 for STERILIZATION INDICATOR STRIP * 008060 manufactured by Surgicot, Inc..
[24024]
The sterilization indicator strips (eto) have been unpredictable in changing color when exposed to ethylene oxide. This has occurred repeatedly and in multiple lots. When four strips were sterilized in a single sterilization container, all four showed different color changes. All eto sterilization criteria was met and all other chemical and bacteriological indicators accurately showed this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001495 |
| MDR Report Key | 38043 |
| Date Received | 1996-09-16 |
| Date of Report | 1994-11-17 |
| Date Added to Maude | 1996-09-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILIZATION INDICATOR STRIP |
| Generic Name | STERILIZATION INDICATOR STRIP |
| Product Code | LRT |
| Date Received | 1996-09-16 |
| Model Number | * |
| Catalog Number | 008060 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 39315 |
| Manufacturer | SURGICOT, INC. |
| Manufacturer Address | 4018 PATRIOT DR RESEARCH TRIANGLE PARK NC 27709 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-16 |