MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-27 for GLUTERALDEHYDE * manufactured by Cottrell Limited.
[78384]
Employee moving table on which jug of gluteral was. Bottle struck floor, cap disengaged and solution splashed in eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 118685 |
| MDR Report Key | 118685 |
| Date Received | 1997-06-27 |
| Date of Report | 1997-02-04 |
| Date of Event | 1997-01-28 |
| Date Facility Aware | 1997-01-28 |
| Report Date | 1997-02-04 |
| Date Reported to Mfgr | 1997-02-05 |
| Date Added to Maude | 1997-09-12 |
| 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 |
| 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 | GLUTERALDEHYDE |
| Generic Name | STERILIZING AGENT |
| Product Code | LFE |
| Date Received | 1997-06-27 |
| Returned To Mfg | 1997-02-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 6K0350 |
| ID Number | * |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 116377 |
| Manufacturer | COTTRELL LIMITED |
| Manufacturer Address | 7399 S. TUSCON WAY ENGLEWOOD CO 80112 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-27 |