MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-01-03 for EYE SHIELD EG701 manufactured by Alcon Laboratories, Inc..
[39371]
Eye shield broke into 4 pieces when pt fell against wall. No pt injury was experienced.
Patient Sequence No: 1, Text Type: D, B5
[19642938]
The device mfr was notified. Alcon was advised that there is no astm standard for strength testing of the acrylic material used in the mfr of this item, and it is not intended to be "shatterproof". Alcon has received no similar reports. No additional info has been received from the user facility despite request. This report was mailed in to fda on: 2/7/97.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-1997-00001 |
| MDR Report Key | 63750 |
| Report Source | 05,06 |
| Date Received | 1997-01-03 |
| Date of Report | 1996-10-28 |
| Date of Event | 1996-10-25 |
| Date Facility Aware | 1996-10-25 |
| Date Reported to Mfgr | 1996-10-28 |
| Date Mfgr Received | 1997-01-10 |
| Date Added to Maude | 1997-01-23 |
| 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 | EYE SHIELD |
| Generic Name | EYE SHIELD |
| Product Code | HOY |
| Date Received | 1997-01-03 |
| Model Number | NA |
| Catalog Number | EG701 |
| Lot Number | UNK |
| ID Number | 510(K) K894724 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 63909 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-03 |