MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-01-09 for KAHN SCLERAL SHIELD ET4600 manufactured by Storz Instrument Company.
[78166]
A laser resurfacing procedure was performed using this shield for the first time. When the shield was removed, the dr observed very large bilateral corneal abrasions on the pt's eyes. The pt experienced a lot of pain and was admitted to the hosp. The next day the abrasions had resolved and the pt was fine.
Patient Sequence No: 1, Text Type: D, B5
[18906926]
The devices were viewed under a 30x microscope. The surface of each sheild was smooth. There were no rough spots or burrs. The cause for the reported injury is not known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932180-1998-00001 |
| MDR Report Key | 143708 |
| Report Source | 05,06 |
| Date Received | 1998-01-09 |
| Date of Report | 1997-12-12 |
| Date of Event | 1997-12-10 |
| Date Facility Aware | 1997-12-10 |
| Report Date | 1997-12-12 |
| Date Reported to Mfgr | 1997-12-12 |
| Date Mfgr Received | 1997-12-12 |
| Date Added to Maude | 1998-01-15 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | KAHN SCLERAL SHIELD |
| Generic Name | SCLERAL SHIELD |
| Product Code | HOY |
| Date Received | 1998-01-09 |
| Model Number | NA |
| Catalog Number | ET4600 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 140164 |
| Manufacturer | STORZ INSTRUMENT COMPANY |
| Manufacturer Address | 499 SOVEREIGN COURT MANCHESTER MO 63011 US |
| Baseline Brand Name | KAHN SCLERAL SHIELD |
| Baseline Generic Name | OPHTHALMIC EYE SHIELD |
| Baseline Model No | NA |
| Baseline Catalog No | ET4600 |
| Baseline ID | NA |
| Baseline Device Family | EYE SHIELD |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-09 |