MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-25 for SMITH * manufactured by Bondet.
[20996276]
On 5/21/2000 rptr received an e-mail from pt advising importer of their injury. Pt was wearing a slider 01 sunglass while skiing. They collided with a fellow skier and fell, hitting their head. The collision and fall caused the glasses to break at one of the temple pieces. The pt received a cut that required 17 stitches. Importer believes the cause of the injury was the collision and fall and not a defect in the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022808-2000-00001 |
| MDR Report Key | 279162 |
| Date Received | 2000-05-25 |
| Date of Report | 2000-05-24 |
| Date of Event | 2000-04-15 |
| Date Facility Aware | 2000-05-21 |
| Report Date | 2000-05-24 |
| Date Added to Maude | 2000-05-26 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | SMITH |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 2000-05-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 270181 |
| Manufacturer | BONDET |
| Manufacturer Address | 29, RUE JJ ROUSSEAU OYONNAX (AIN) FR 01104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-05-25 |