MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-12 for CROUCH CORNEAL PROTECTOR E5699 * manufactured by Bausch & Lomb (storz Ophthalmes).
[240799]
Pt undergoing surgical correction of multipe facial fractures sustained bilateral corneal abrasions from the use of corneal protectors. Corneal protectors placed at start of procedure by surgeons (eyes were lubricated prior to placement of pretectors). Procedure lasted greater than 8 hours. Upon removal of protectors, both corneas appeared opacified. Exam by ophthalmology noted bilateral corneal abrasions in a circular pattern. Pt experienced blurred vision post-operatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 378519 |
| MDR Report Key | 378519 |
| Date Received | 2001-12-12 |
| Date of Report | 2001-11-12 |
| Date of Event | 2001-10-26 |
| Date Facility Aware | 2001-11-06 |
| Report Date | 2001-11-12 |
| Date Added to Maude | 2002-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROUCH CORNEAL PROTECTOR |
| Generic Name | CORNEAL PROTECTOR |
| Product Code | MOE |
| Date Received | 2001-12-12 |
| Model Number | E5699 |
| Catalog Number | * |
| Lot Number | S 7742 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 367561 |
| Manufacturer | BAUSCH & LOMB (STORZ OPHTHALMES) |
| Manufacturer Address | 3365 TREECOURT INDUSTRIAL BLVD ST. LOUIS MO 63122 US |
| Baseline Brand Name | CROUCH CORNEAL PROTECTOR |
| Baseline Generic Name | CORNEAL PROTECTOR |
| Baseline Model No | NA |
| Baseline Catalog No | E5699 |
| Baseline ID | NA |
| Baseline Device Family | SHIELD EYE OPHTHALMIC CLASS I |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833256 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-12-12 |