MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-11-01 for PROSHIELD 8065-1014-01 manufactured by Alcon Laboratories, Inc..
[31555]
Physician observed shield did not dissolve after 24 hrs and it folded over itself, became hard and abraided the corneal. This event resolved after 3 days and was treated with pressures patching. He reports he routinely soaks the shield in ancef and solumedrol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-1996-00010 |
| MDR Report Key | 47157 |
| Report Source | 05,06 |
| Date Received | 1996-11-01 |
| Date of Report | 1996-08-15 |
| Report Date | 1996-08-15 |
| Date Reported to Mfgr | 1996-08-15 |
| Date Mfgr Received | 1996-10-03 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 1996-11-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSHIELD |
| Generic Name | CORNEAL SHILED |
| Product Code | MOE |
| Date Received | 1996-11-01 |
| Model Number | NA |
| Catalog Number | 8065-1014-01 |
| Lot Number | 6201610 |
| ID Number | 510K902558 |
| Device Expiration Date | 1998-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 47961 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-01 |