MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for CORNEAL SHIELDS H71 manufactured by Cynosure, Inc. Dba Ellman.
[35530145]
Customer is unresponsive as to condition post treatment and no pictures have been provided. Evaluation of corneal eye shield has not been able to be performed. A medical device report is being filed as an unconfirmed but potentially serious injury may have occurred. Device was unable to be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[35530146]
Customer reported that there is a default on the edge of the corneal eye shield which had caused an ocular lesion when the eye shield was used. This resulted in bleeding under the conjunctiva and patient was given collyrium.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428235-2016-00001 |
| MDR Report Key | 5355993 |
| Date Received | 2016-01-08 |
| Date of Report | 2016-01-08 |
| Date of Event | 2015-12-11 |
| Date Mfgr Received | 2015-12-11 |
| Date Added to Maude | 2016-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer City | NY |
| Manufacturer Country | US |
| Manufacturer G1 | CYNOSURE, INC. DBA ELLMAN |
| Manufacturer Street | 400 KARIN LANE |
| Manufacturer City | HICKSVILLE NY 11801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CORNEAL SHIELDS |
| Generic Name | OPTHALMIC EYE SHIELD H71 |
| Product Code | MOE |
| Date Received | 2016-01-08 |
| Model Number | H71 |
| Catalog Number | H71 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE, INC. DBA ELLMAN |
| Manufacturer Address | HICKSVILLE NY 11801 US 11801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-08 |