MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for SHARN ANESTHESIA EYEGARD S-2020 manufactured by Sharn Inc..
[101771233]
A pt received total iv anesthesia without a protected airway. Her eyes were protected with the s-2020 eyegards. When the drape was removed after surgery, the surgical team saw the bottom of the eye tape had come loose and the child's eye had been open during the procedure. Postoperative, the pt was complaining of severe eye pain. Ophthalmology was consulted. The pt was diagnosed with bilateral keratopathy as a result of incomplete closure of her eyes during the procedure. She required 24 hrs of antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075672 |
| MDR Report Key | 7316587 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-03-02 |
| Date of Event | 2017-12-18 |
| Date Added to Maude | 2018-03-06 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHARN ANESTHESIA EYEGARD |
| Generic Name | SHEILD, EYE, OPHTHALMIC |
| Product Code | HOY |
| Date Received | 2018-03-05 |
| Model Number | S-2020 |
| Lot Number | 2180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHARN INC. |
| Manufacturer Address | CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-05 |