MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-04 for GOLDSEAL MICROSCOPE SLIDE 3050 (M6162) manufactured by Erie Scientific Corp..
[18597172]
When lab worker placed the slide on the counter, a glass chip from the slide flew up and hit her in the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483039-1995-00005 |
| MDR Report Key | 24554 |
| Date Received | 1995-07-28 |
| Date of Report | 1995-07-27 |
| Date of Event | 1995-06-28 |
| Date Facility Aware | 1995-07-21 |
| Report Date | 1995-07-27 |
| Date Reported to FDA | 1995-07-27 |
| Date Reported to Mfgr | 1995-07-27 |
| Date Added to Maude | 1995-08-17 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | GOLDSEAL MICROSCOPE SLIDE |
| Generic Name | MICROSCOPE SLIDE |
| Product Code | KEW |
| Date Received | 1995-08-04 |
| Model Number | NA |
| Catalog Number | 3050 (M6162) |
| Lot Number | 1915K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24919 |
| Manufacturer | ERIE SCIENTIFIC CORP. |
| Manufacturer Address | PORTSMOUTH INDUSTRIAL PARK PORTSMOUTH NH 03801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-07-28 |