MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-08 for PRESCOTT'S-ZEISS STERILE HAND GRIP 302627-9001 PHPO13KPLT manufactured by Prescott's Monument Co.
[5788523]
Small black piece of plastic fell into patient's left eye, which had lidocaine jelly in it, surgeon removed piece and wiped area with betadine and thoroughly flushed eye, plastic was from microscope handle cover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042638 |
| MDR Report Key | 4768763 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-04-13 |
| Date Added to Maude | 2015-05-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESCOTT'S-ZEISS STERILE HAND GRIP |
| Generic Name | ZEISS STERILE HANDGRIP |
| Product Code | HOZ |
| Date Received | 2015-05-08 |
| Model Number | 302627-9001 |
| Catalog Number | PHPO13KPLT |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRESCOTT'S MONUMENT CO |
| Manufacturer Address | 18940 MICROSCOPE WAY MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-08 |