MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1996-10-16 for SERENGETI DRIVERS DR5239 manufactured by Corning Sunglass Products.
[23590]
A consumer wearing a pair of co's sunglasses was struck in the right lens by a cattle herding stick, or cane, wielded by his father. The father swung the stick back over his head preparatory to swinging forward. The tip of the stick hit the right lens causing it to shatter. The implant also deformed the metal frame eyewire. A resultant cut to the right cheek required stitches to close. A lens particle became embedded in the upper eyelid and required removal. The stitches have since been removed and no further treatment is anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317452-1996-00005 |
| MDR Report Key | 43482 |
| Report Source | 04 |
| Date Received | 1996-10-16 |
| Date of Report | 1996-10-15 |
| Date of Event | 1996-09-22 |
| Date Mfgr Received | 1996-10-03 |
| Device Manufacturer Date | 1991-01-01 |
| Date Added to Maude | 1996-10-23 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERENGETI DRIVERS |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 1996-10-16 |
| Returned To Mfg | 1996-10-03 |
| Model Number | NA |
| Catalog Number | DR5239 |
| Lot Number | DR5239R |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 44441 |
| Manufacturer | CORNING SUNGLASS PRODUCTS |
| Manufacturer Address | 203 COLONIAL DR HORSEHEADS NY 14845 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-10-16 |