MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-07 for PRO-SHIELDS. INFANT EYE SHIELD * 23518 manufactured by Pro-optics, Inc..
[66265]
Four day old baby boy in nicu under phototherapy lamp, when alarms alerted nurse, who evaluated pt and observed a saturation of 64%, heart rate of 70/min and cyanosis. Nurse observed that the eye pads were over the baby's nose and removed them. Immediately the baby responded to touch, hr increased to 127 and saturation increased to 99%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011643 |
| MDR Report Key | 103389 |
| Date Received | 1997-07-07 |
| Date of Report | 1997-06-19 |
| Date of Event | 1997-06-10 |
| Date Added to Maude | 1997-07-09 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO-SHIELDS. INFANT EYE SHIELD |
| Generic Name | EYE SHIELD |
| Product Code | HOY |
| Date Received | 1997-07-07 |
| Model Number | * |
| Catalog Number | 23518 |
| Lot Number | 340 |
| ID Number | ORDER'S 61902 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 101731 |
| Manufacturer | PRO-OPTICS, INC. |
| Manufacturer Address | 317 WOODWORK LN. PALATINE IL 60067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-07 |